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*UPGRADE IN PROGRESS* -- CareerCircle is upgrading its capabilities and as a result the system may be temporarily unavailable as we bring new capabilities and infrastructure online to better serve our members.&nbsp; If you receive an error during this timeframe please bear with us as we're working to improve our system and you may need to retry that operation at a later time.&nbsp; &nbsp;

Job Description Position Description: Clinical Research Manager - Oncology (Remote) This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for several countries in a cluster. Responsibilities include, but are not limited to: <ul><li>Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).</li><li>Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.</li><li>Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.</li><li>Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.</li><li>Performs Quality control visits as required.</li><li>Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM). </li><li>Responsible for creating and executing a local risk management plan for assigned studies.</li><li>Ensures compliance with CTMS, eTMF and other key systems in assigned studies.</li><li>Escalates as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).</li><li>Identifies and shares best practices across clinical trials, countries, clusters. </li><li>Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies. </li><li>Country POC for programmatically outsourced trials for assigned protocols.</li><li>As a customer-facing role, this position will build business relationships and represent our Company with investigators.</li><li>Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).</li><li>Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH and Regional Operations.</li><li>Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed. </li></ul>Extent of Travel:<ul><li>Up to 30% of working time</li></ul>Expectations:<ul><li>Knowledge in Project Management and site management.</li><li>Strong organizational skills with demonstrated success required.</li><li>Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD</li><li>Requires strong understanding of local regulatory environment.</li><li>Strong scientific and clinical research knowledge is required.</li><li>Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.</li><li>Experience functioning as a key link between Country Operations and Clinical Trial Teams.</li><li>Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.</li><li>Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.</li><li>Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication. Strategic thinking.</li><li>Ability to work efficiently in a remote and virtual environment.</li><li>Understand cultural diversity.</li><li>The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.</li></ul> Position Qualifications : Education Minimum Requirement: <ul><li>Required: Bachelor degree in Science (or comparable)</li><li>Preferred: Advanced degree, (e.g., Master degree, MD, PhD)</li></ul>Required Experience and Skills: <ul><li>Required: Minimum 5 years of experience in clinical research</li></ul>Behavioral Competency Expectations:<ul><li>Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our Company's Research & Development Division , Global Clinical Development (GCD) and GCTO.</li><li>Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.</li><li>Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption.</li><li>Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations.</li><li>Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.</li></ul>Preferred Experience and Skills:<ul><li>Oncology experience preferred</li><li>CRA Experience preferred</li></ul> MRLGCTO #EligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $135,500.00 - $213,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: No Hazardous Material(s): NA Requisition ID:R292012

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Clinical Research Manager - Oncology (Remote)

Job Description Our Oncology team is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of forward-thinking individuals achieve this through an unwavering commitment to support accessibility to medicine, providing new therapeutic solutions, and collaborating with governments and payers to ensure that people who need medicines have access to them. Our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. Associate Director, HCP Pan Tumor Strategy, US Oncology (Scientific Strategy & LCM, Marketing)      We are currently recruiting for an Associate Director, HCP Pan Tumor Strategy (Scientific Strategy & LCM, Marketing), US Oncology. This individual will be responsible for:<ul><li>Developing scientific strategy, narrative & market segmentation strategies for oncologists, urologists, surgeons, and multi-disciplinary teams at the portfolio level</li><li>Leading scientific strategy related to LCM and launch planning/execution - particularly related to new formulations, administrations, combinations indications and dosing to grow brand equity in coordination with the broader team </li><li>Lead the promotional medical education strategy to maximize Pan Tumor portfolio strategy while enhancing the experience for customers</li><li>Congress planning and strategy for large national/regional conferences</li></ul>The position is based in Upper Gwynedd, PA reporting to a Director, HCP Pan Tumor Strategy, US Oncology. This position will require outstanding leadership and collaboration in many areas including HCP marketing and strategy development, scientific acumen including medical education, launch planning, market research, relationship building, budget management and ensuring flawless launch execution from the team. Candidate will require the ability to deliver the business today, while simultaneously planning for future indications, and a proven track record to work successfully under tight and often fluctuating timelines. Additional duties & responsibilities include and may not be limited to the following: <ul><li>Scientific strategy development and launch planning/execution - particularly related to new formulations, administrations, combination indications and dosing to grow brand equity in coordination with the broader team </li><li> Collaborate closely across extended matrix including Global, tumor level teams, marketing execution, digital teams and all relevant stakeholders to inform workstreams </li><li>Partner with market research, global marketing, competitive intelligence, and analytics teams to identify insight gaps, generate key insights, and enhance LCM planning</li><li>Leverage SL insights to enhance strategy and tactics across MDT's including Med-Oncs and Surgeons in both academic and community settings</li><li>Possess a strong understanding of the Oncology competitive landscape with an ability to see and predict market trends</li><li>Work closely with CI team and track timing of competitive trials, and potential implications to our business. </li><li>Work closely with medical affairs team to provide Pan Tumor marketing viewpoint on advisory boards and other key scientific initiatives</li><li>Drive executional excellence by pulling through the appropriate Pan Tumor scientific narrative into medical education resources and programs (Lectures/ PDGs/ IPPs), optimizing speaker bureau, and working closely with the customer facing teams</li><li>Identify gaps in current medical education needs and develop innovative approaches/resources</li><li>Manage and provide guidance to multiple agency partners</li><li>Work closely with digital engagement colleagues to pull through scientific strategy in Omnichannel marketing plan</li><li>Collaborate with existing Pan Tumor team members and other key stakeholders to prioritize work and facilitate internal resource trade-offs as needed, e.g., budget, PRT review time. Escalate issues that represent significant barriers to execution and/or business impact</li><li>Think innovatively, challenge status quo, and gain sponsorship/ support to address gaps</li><li>Budget management and expense tracking</li></ul> Qualifications: Education Minimum Requirements: <ul><li>Required: BA/BS </li><li>Preferred: Advance Degree (MBA, PharmD)</li></ul> Required Experience and Skills: <ul><li>Minimum of 5 years Pharmaceutical business experience</li><li>Minimum of 3 years successful brand marketing or closely related discipline experience</li><li>Excels when addressing ambiguity, working outside existing processes or structures. </li><li>Ability to establish networks across stakeholders to drive influence and alignment</li><li>Test and learn mindset to drive culture of innovation</li><li>Focused mindset on customer experience</li><li>Committed to applying agile values, principles, and practices</li><li>Requires approximately 15-20% travel, including some weekends</li></ul> Preferred Experience and Skills <ul><li>Oncology Marketing experience, ideally with a focus in Scientific Strategy and portfolio marketing</li><li>Sales experience</li><li>Product/Indication launch experience - preferably in oncology</li><li>Previous promotion and medical education development experience</li><li>Experience in developing brand strategy and implementation across multiple indications/brands</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): n/a Requisition ID:R290987

Associate Director, HCP Pan Tumor Strategy, US Oncology

Job Description The Discovery Analytical Research group within Analytical Enabling Capabilities (Analytical R&D) is seeking applicants for an Associate Principal Scientist position available at its South San Francisco, California research facility. The successful candidate will contribute to the efforts in enabling the discovery of new drug candidates including small molecules, biologics and other emerging modalities. Key deliverables will include the development, implementation, and execution of analytical measurement technologies that may accelerate the pace of discovery research and influence molecular design. The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment. A broad range of tools (e.g. chromatography, electrophoresis, mass spectrometry, spectroscopy) are leveraged and new technologies are developed to influence selection of new drug candidates and enhance scalability and robustness. The ideal candidate will have knowledge in the biopharmaceutical discovery and development fields, and proficiency in one or more areas such as separation techniques, high-resolution mass spectrometry, and lab automation. Strong fundamental knowledge in recent advances in analytical technologies is highly desired. Applicants must have effective organizational, multi-tasking, oral /written communications skills, scientific leadership, and a desire to conduct research and publish in peer-reviewed scientific journals. Primary Responsibilities: <ul><li> Enable discovery partner groups with advanced analytical methods </li><li> Represent the discovery analytical research group in project teams </li><li> Solve challenging problems by application of one or more analytical technique, including but not limited to, liquid chromatography, gas chromatography, capillary electrophoresis, ion chromatography, size exclusion chromatography, two dimensional techniques and high-resolution mass spectrometry. </li><li> Explore and develop new technologies applicable to the field of measurement science. </li><li> Demonstrate effective multitasking, prioritization and problem-solving skills in the planning and execution of experiments. </li><li> The successful candidate must be able to effectively collaborate in a fast-paced, integrated, multidisciplinary team environment. </li></ul> Education Minimum Requirements: <ul><li> Ph.D. in Analytical Chemistry or related field with 3+ years of biopharmaceutical industry experience. </li></ul> Required Experience and Skills: <ul><li> Strong background and extensive hands-on experience in separation techniques (UPLC, cIEF, CZE, SEC, HIC, IEX), hyphenated techniques (e.g. LC-MS, GC-MS) and high-resolution mass spectrometry (structure elucidation) is required. </li><li> Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills. </li><li> Ability to deliver complex objectives under challenging timelines in a rapidly changing environment. </li><li> Ability to work in a team environment with cross-functional interactions. </li></ul> Preferred Experience and Skills: <ul><li> Experience utilizing Python or similar for high throughput data processing. </li><li> Experience with high throughput analytical methods. </li><li> Demonstrated scientific ability through publications in peer reviewed journals and presentations in scientific conferences. </li><li> Understanding of biochemistry and organic chemistry. </li><li> Familiarity with electronic laboratory notebook applications and good documentation practices. </li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #EligibleforERP Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $151,900.00 - $239,200.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): Standard lab chemicals Requisition ID:R291451

Associate Principal Scientist, Discovery Analytical Research / AR&D

Job Description We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science" that great medicines can make a significant impact to our world. We believe that a research driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. We have an exciting, new opportunity for an Principal Scientist, Health Economics & Decision Sciences (HEDS) to join our team. The preferred location is Rahway, NJ; alternative locations in USA (Boston, MA, West Point, PA, or Philadelphia, PA) and UK (London) are possible. HEDS is part of our company's Biostatistics and Research Decision Sciences group, and works in collaboration with internal and external partners (such as the Center for Observational and Real-World Evidence, CORE) to generate the evidence to support scientific and commercial value of our company's portfolio to optimize access, reimbursement, and patient outcomes. Our group provides strategic and technical leadership to enable patient access, measure and quantify the value of our products, inform internal and external decisions, and shape methodology and external health policy and practice. This position will focus on oncology products. Under the direction of a HEDS Senior Director, the Principal Scientist provides strategic development and use of industry-leading predictive and economic models to enhance our understanding of disease and to quantify and communicate the value of our oncology products to patients, providers, and payers.<ul><li>Serve as the HEDS lead for one or more value evidence teams to develop health economic, disease, and predictive models to enable business insights for the product.</li><li>Utilize discovery, real world evidence, clinical trial and published data, and publicly available information and tools to provide economic and integrated models to answer key questions in all phases of drug and vaccine development - Phase I through loss of data exclusivity.</li><li>Advance the use of integrated quantitative approaches, focusing on economic, disease, and predictive modeling and simulation in partnership with other internal groups and external organizations.</li><li>Development and maintenance of health quality global health economic models and tools in-house or in collaboration with external vendors to provide critical business insights and fully demonstrate the value of our company's products.</li><li>Support and training of HEDS models and tools to support country/regional team adaptations and communications with external stakeholders.</li><li>Dissemination of health economic data via presentations at congresses and publications in scientific journals.</li><li>Work closely with external collaborators (clinical/economic thought leaders, payer/HTA experts, alliance partners) and internal teams to ensure that new methodologies, models and advanced analytics are fully utilized for our products.</li><li>Maintain awareness of external data, modeling methodologies and IT tools to collaborate across relevant internal stakeholders to enhance our company's capabilities in health economic modeling, simulation, and data visualization.</li><li>Partner in defining and implementing the HEDS vision and strategy to develop an innovative, world class Center of Excellence.</li><li>Ensure sharing of work product and relevant best practices across the company's enterprise.</li></ul>Education<ul><li>PhD (preferred) or Masters degree, in Health Economics, Biostatistics, Health Services Research, Actuarial Sciences or a closely related, quantitative field</li></ul>Required Experience and Skills:<ul><li>Relevant experience in health economics and outcomes research (HEOR) of 5 or more years beyond PhD (or 7 or more years beyond Masters degree)</li><li>Highly experienced in the economic evaluation of oncology drugs and interventions</li><li>Strong expertise in the conceptualization, design, development and dissemination of health economic model approaches to enable internal and external decisions</li><li>Leadership skills, with experience in managing resources and driving implementation</li><li>Track record of submissions to Health Technology Assessment bodies and research publications in conferences and peer-reviewed journals</li><li>Strong interpersonal, organizational and communication skills with ability to interact with individuals from a variety of disciplines</li><li>Understanding of the market access environment and challenges in the US and key international markets</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. BARDS2020 #eligibleforERP #DATA2020 Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Requisition ID:R292120

Principal Scientist, Health Economics and Decision Sciences

Job Description Job Description: We are looking for a manager to lead and manage the validation and testing activities for our platform products. This role will need will collaborate with cross-functional teams, including development, product management, and quality assurance, to ensure the successful delivery of high-quality software solutions. Responsibilities: <ul><li>Develop and implement an effective validation and testing strategy for the platform team, in line with industry best practices and standards.</li><li>Lead and manage a team of validation and test engineers, providing guidance, coaching, and mentoring to drive professional growth and ensure team success.</li><li>Define and oversee test plans, ensuring comprehensive coverage of functional and non-functional requirements. Execute and/or coordinate testing activities, including test case creation, test execution, and defect tracking.</li><li>Drive the adoption of test automation frameworks and tools to increase testing efficiency and effectiveness. Collaborate with the development team to integrate test automation into the CI/CD pipeline.</li><li>Collaborate with infrastructure and DevOps teams to establish and maintain test environments, ensuring they accurately represent production environments.</li><li>Define and monitor key test metrics to measure the effectiveness of the validation and testing process. Generate regular reports, highlighting test results, defects, and overall quality status.</li><li>Work closely with product management and development teams to understand product requirements, provide input on design for testability, and ensure that quality is built into the software development process.</li><li>Continuously evaluate and improve the validation and testing processes, tools, and techniques, enhancing productivity and quality in line with industry best practices.</li></ul> Education: <ul><li>Bachelor's degree in computer science, Engineering, or a related field, systems analysis, or a related study.</li></ul> Experience/Skills: <ul><li>Proven experience in a software testing or quality assurance role, with at least ten (10) years of experience in a leadership or management capacity.</li><li>Experience working with SaaS and COTS products.</li><li>Strong knowledge of software testing methodologies, tools, and best practices.</li><li>Experience in test automation frameworks and tools, such as HP ALM, Robotic testing framework.</li><li>Familiarity with Agile/Scrum methodologies and experience in testing within an Agile environment.</li><li>Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams and stakeholders.</li><li>Strong analytical and problem-solving abilities, with a keen attention to detail.</li><li>Experience with continuous integration and delivery (CI/CD) practices is a plus.</li><li>Experience in developing and maintaining validation deliverables, including validation plans, protocols, test scripts, test summary reports, and validation reports in alignment with GCP and 21 CFR Part 11 requirements.</li><li>Risk-based validation approach: Knowledge and application of risk-based validation strategies, such as risk assessment, to prioritize validation activities and focus testing efforts on critical system functionalities.</li><li>Change control and deviation management: Proficient in managing change control processes and identifying deviations during validation activities. Ability to assess and mitigate risks associated with changes to validated systems.</li><li>Regulatory audits and inspections: Familiarity with regulatory audit and inspection processes, including the ability to provide documentation and evidence of validation activities to regulatory authorities.</li><li>Clinical systems knowledge highly preferred.</li></ul>#EligibleforERP MRLGCTO #ONEGDMS NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $135,500.00 - $213,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): No Requisition ID:R288757

Business Validation Manager (Hybrid)

Job Description We are looking for an energetic, self-starter to join our Enterprise Information Technology team to help us identify and deliver digital and technology solutions that drive business outcomes for the Ethics & Compliance Office (ECO or the Business") in areas such as Antibribery & Corruption, Research Compliance, and Global Trade Compliance . The Technical Product Manager is a key member of the Legal, Compliance and Security Value team. The Technical Product Manager plays a critical role in implementing, managing , and overseeing the IT products that enable the Business's strategic priorities . They are responsible for creating a wide range of documentation to captur e and catalog comprehensive bu siness requirements essential for the success ful delivery of n ew or upgraded IT solutions. Additionally, they initiate dialog within each product area 's Business clients to identify pain points and emerging business demand provid ing this feedback on new business opportunities into the Value Team's t echnology roadmap. They possess a strong understanding of enterprise technology solutions and the ability to anticipate and prioritize the needs of the B usiness . T his rol e leverages business analyst skills to develop a complete understanding of the technolog y requirements . They must have a good grasp of the current technology portfolio , ability to plan and execute on the technology roadmap, and the agility to address ad-hoc support requests when appropriate . The ability to identify and analyz e t he organization's technology ecosystem to find existing enterprise solutions to support new business demand is desirable . A key aspect of the Technical Product Manager's role is to apply standard techniques and tools to analyze and monitor the performance of specified products. This includes capturing metrics such as Net Promoter Score (NPS) to ensure continuous improvement. They actively support problem resolution and take necessary actions based on feedback and usage of the products in use. Key Responsibilities <ul><li> Owns and manages a product throughout its lifecycle. </li><li> Acts as a liaison between B usiness stakeholders and development teams by building and maintaining effective relationships with stakeholders at various levels of the organization. </li><li> Defines the overall product vision and strategy, emphasizing value, business outcome, and user experience. </li><li> Facilitates effective communication, manages stakeholders' expectations, and ensures desired outcomes are achieved. </li><li> Works closely with t echnical subject matter experts (SMEs) and job families, such as Information Architecture and Software Engineering. </li><li> Ensures compliance applications and platforms adhere to relevant regulatory and industry standards, collaborating with stakeholders to identify and remediate gaps. </li><li> Actively participates in Agile development processes, prioritizing and delivering product features iteratively. </li><li> Makes product decisions aligned with Business objectives and industry best practices . </li><li> Strategically manages one or more pro ducts to meet specific goals and objectives , including resource allocation, risk management, and portfolio optimization. </li><li> Develops and regularly calibrates metrics to evaluate the performance of each product. </li><li> Drives continuous product discovery to understand user needs and translate them into actionable solutions and product backlog. </li><li> Creates, maintains , and prioritizes the product backlog to maximize value delivery and ensure long-term sustainability. </li><li> Drives release and support planning and execution, including go- live strategies. </li><li> Manages the day-to-day activities related to internal or external technology resources or suppliers . </li><li> Tracks fina n cial metrics with an understanding of total cost of ownership (TCO) of the product. </li><li> S olicits input from Business subject matter experts (SMEs) to establish the requirements baseline. </li><li> Defines and manages scoping, requirements definition, and prioritization activities for both large and small-scale changes and assists with more complex change initiatives. </li><li> Follows agreed-upon standards and applies appropriate techniques to elicit and document detailed requirements. </li><li> Investigates, manages, and applies authorized requests for changes to baselined requirements, following the change management policy. </li></ul> Education <ul><li> Bachelors in IT, Engineering, Computer Science, or related field . </li></ul> Required Skills <ul><li> Minimum 5 years of experience in product development and road mapping ability to define product vision, set strategic goals, and drive product development throughout the lifecycle. </li><li> Owners hip and facilitation of requirement gathering sessions with stakeholders and subject matter experts (SMEs). </li><li> Expertise translat ing business requirements into effective technical solutions that meet user needs and deliver value. </li><li> Familiarity with Agile methodologies and experience in the system development life cycle (SDLC) policies. </li><li> Experience in business process architecture and workflow modeling. </li><li> Expertise in system integration, migration, data mapping and data modeling. </li><li> Strong communication and stakeholder management skills , including presentations to internal customers and executive leadership. </li></ul> Desired Skills <ul><li> Experience working in the pharmaceutical or healthcare industry is a plus. </li><li> Strong analytical, problem-solving, and communication skills. </li><li> Proficient in requirements management, including scoping, definition, and prioritization of requirements, ensuring alignment with business objectives . </li><li> Knowledge of corporate compliance business processes ( e.g. , Anti-Bribery & Corruption) including relevant regulations and standards, is beneficial. </li><li> Capable of developing and implementing effective controls to streamline processes and improve operational efficiency. </li><li> Skilled in strategic planning, with the ability to analyze market trends, identify opportunities, and develop plans for long-term business growth. </li><li> E xpertise in solution design, including the ability to translate business requirements into effective technical solutions that meet user needs and deliver value. </li><li> Proficient in asset management, ensuring proper utilization and optimization of resources to achieve organizational objectives . </li><li> Experience with MS PowerPlatform. </li></ul> #eligibleforerp NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $111,400.00 - $175,300.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Required Skills: Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills: Requisition ID:R291169

Technical Product Manager - Antibribery, Corruption and Compliance (Hybrid)

Job Description We are looking for an energetic, self-starter to join our Enterprise Information Technology team to help us identify and deliver digital and technology solutions that drive business outcomes for the Ethics & Compliance Office (ECO or the Business") in areas such as Privacy and Policy Management . The Technical Product Manager is a key member of the Legal, Compliance and Security Value team. The Technical Product Manager plays a critical role in implementing, managing, and overseeing the IT products that enable the Business's strategic priorities . They are responsible for creating a wide range of documentation to captur e and catalog comprehensive business requirements essential for the successful delivery of new or upgraded IT solutions. Additionally, they initiate dialog within each product area 's Business clients to identify pain points and emerging business demand provid ing this feedback on new business opportunities into the Value Team's technology roadmap. They possess a strong understanding of enterprise technology solutions and the ability to anticipate and prioritize the needs of the B usiness . This role leverages solution architect skills to develop a complete understanding of the technology requirements . They must have a good grasp of the current technology portfolio , ability to plan and execute on the technology roadmap, and the agility to address ad-hoc support requests when appropriate . The ability to identify and analyze the organization's technology ecosystem to find existing enterprise solutions to support new business demand is desirable . A key aspect of the Technical Product Manager's role is to apply standard techniques and tools to analyze and monitor the performance of specified products. This includes capturing metrics such as Net Promoter Score (NPS) to ensure continuous improvement. They actively support problem resolution and take necessary actions based on feedback and usage of the products in use. Key Responsibilities <ul><li> Owns and manages a product throughout its lifecycle. </li><li> Acts as a liaison between B usiness stakeholders and development teams by building and maintaining effective relationships with stakeholders at various levels of the organization. </li><li> Defines the overall product vision and strategy, emphasizing value, business outcome, and user experience. </li><li> Facilitates effective communication, manages stakeholders' expectations, and ensures desired outcomes are achieved. </li><li> Works closely with t echnical subject matter experts (SMEs) and job families, such as Information Architecture and Software Engineering. </li><li> Ensures compliance applications and platforms adhere to relevant regulatory and industry standards, collaborating with stakeholders to identify and remediate gaps. </li><li> Actively participates in Agile development processes, prioritizing and delivering product features iteratively. </li><li> Makes product decisions aligned with Business objectives and industry best practices . </li><li> Strategically manages one or more pro ducts to meet specific goals and objectives , including resource allocation, risk management, and portfolio optimization. </li><li> Develops and regularly calibrates metrics to evaluate the performance of each product. </li><li> Drives continuous product discovery to understand user needs and translate them into actionable solutions and product backlog. </li><li> Creates, maintains , and prioritizes the product backlog to maximize value delivery and ensure long-term sustainability. </li><li> Drives release and support planning and execution, including go- live strategies. Manages the day-to-day activities related to internal or external technology resources or suppliers . </li><li> Tracks fina n cial metrics with an understanding of total cost of ownership (TCO) of the product. </li><li> S olicits input from Business subject matter experts (SMEs) to establish the requirements baseline. </li><li> Defines and manages scoping, requirements definition, and prioritization activities for both large and small-scale changes and assists with more complex change initiatives. </li><li> Follows agreed-upon standards and applies appropriate techniques to elicit and document detailed requirements. </li><li> Investigates, manages, and applies authorized requests for changes to baselined requirements, following the change management policy. </li></ul> Education <ul><li> Bachelors in IT, Engineering, Computer Science, or related field. </li></ul> Required Skills <ul><li> Minimum 5 years of experience in product development and road mapping ability to define product vision, set strategic goals, and drive product development throughout the lifecycle. </li><li> 5 or more years of experience in leading and managing internal and external matrixed development and delivery teams. </li><li> Proficiency in technical resource management, defect resolution, feature development, and platform hardening. </li><li> E xpertise in solution design, including the ability to translate business requirements into effective technical solutions that meet user needs and deliver value. </li><li> Familiarity with Agile methodologies and experience in the system development life cycle (SDLC) policies. </li><li> Experience in business process architecture and workflow modeling. </li><li> Expertise in system integration, migration, data mapping and data modeling. </li><li> Strong communication and stakeholder management skills , including presentations to internal customers and executive leadership. </li></ul> Desired Skills <ul><li> Experience working in the pharmaceutical or healthcare industry is a plus. </li><li> Strong analytical, problem-solving, and com munication skills. </li><li> Proficient in requirements management, including scoping, definition, and prioritization of requirements, ensuring alignment with business objectives . </li><li> Knowledge of corporate compliance business processes ( e.g. , Privacy ) including relevant regulations and standards, is beneficial. </li><li> Capable of developing and implementing effective controls to streamline processes and improve operational efficiency. </li><li> Skilled in strategic planning, with the ability to analyze market trends, identify opportunities, and develop plans for long-term business growth. </li><li> Proficient in asset management, ensuring proper utilization and optimization of resources to achieve organizational objectives . </li><li> Knowledge and experience with internal and external API integrations. </li><li> Experience with MS PowerPlatform. </li></ul> #eligibleforer NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $111,400.00 - $175,300.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Required Skills: Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills: Requisition ID:R292315

Technical Product Manager - Privacy and Policy Management Products (Hybrid)

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! We are seeking a Growth and Improvement minded Quality & Compliance 3D Technologies Senior Scientist that can help drive our Strategic Operating Priorities. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Our 3D Technologies enterprise team operates as a business partner for raised challenges and problems to propose ideas and innovative solutions that enable new organizational capabilities. Our mission statement is to democratize inventing and make it easy and accessible to anyone at our company. We collaborate internationally across the globe to deliver the services and solutions that help everyone to be more productive and enable innovation. This role will provide support for our Quality & Compliance for cGMP components strategy. Key Responsibilities:<ul><li>Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion</li><li>Deep and comprehensive understanding of 3D scanning technology, meshes and point clouds, and refining scans</li><li>Thorough experience with all slicing software from basic free software to proprietary and higher complexity software (Materialise Magics, Simplify3d, Meshmixer, etc) </li><li>Advanced understanding of mechanical systems and industrial 3D printing machines, as well as post-processing machines. Ability to work on and troubleshoot varied mechanical systems back to working order.</li><li>Experience with vapor smoothing post-processing machines and the creation and management of solvent recipes</li><li>Experience with scalable vector graphics and laser cutting software, computerized numerical code for toolpaths on automated mills and routers. </li><li>Material and parts testing</li><li>Collaborate on in-house testing parameters and strategy for internal vs. external testing</li><li>Execute on in-house testing</li><li>Own, manage and perform or schedule preventative maintenance for the material testing equipment</li><li>Facilitate external and company-internal collaboration for material and part testing</li><li>New materials and equipment testing</li><li>Identify new equipment or material candidates in the industry</li><li>Install and qualify new equipment in the lab</li><li>Develop material print profiles for machines that need custom parameter adjustments </li><li>Develop SOPs for use of equipment, in collaboration with the manufacturer as appropriate, with the intention to eventually hand equipment off to the broader group for production work</li><li>Collaborate with other lab locations, vendors or Co-Lo partners to develop SOPs for new equipment and materials designated for other sites in our network</li><li>Internal communication and standards</li><li>Assist in developing SOPs, best practices and Quality & Compliance related knowledge to both share internally to our group, and in a data repository, such as OneDrive</li><li>Assist in organizing material testing information in a company-wide understandable format and accessible location, such as a SharePoint site</li></ul> Position Qualifications : Education Minimum Requirement: <ul><li>High School Diploma required.</li></ul>Required Experience and Skills:<ul><li>Minimum of 1 years experience in design fabrication/manufacturing applications.</li><li>Minimum of 1 years' SolidWorks, Fusion 360 or Creo 3D cad software.</li><li>Minimum of 1 years operating 3D printing and slicer software.</li><li>Minimum of 1 year hands-on experience with a polymer fabrication technology (e.g. 3D Printing or Injection Molding).</li><li>Minimum of 1 year using and maintaining industrial, large format 3D printing and reclamation machines.</li><li>Minimum of 1 year experience in using and maintaining vapor smoothing post-processing equipment.</li><li>Ability to build and work across divisions as well as internal and external teams and vendors.</li><li>Fine attention to detail in post-processing parts to ensure success in IQ OQ PQ qualification.</li><li>Excellent organizational skills to manage a wide range of data types</li><li>Excellent communication to convert complicated information into a format the average person in an unrelated discipline can understand</li><li>Advanced ability to communicate and collaborate effectively </li><li>Analytical thinking and logical reasoning for troubleshooting machine problems </li></ul>Preferred Experience and Skills:<ul><li>Hands on experience in operating and maintaining 3D printers and industrial machining equipment</li><li>Material science experience specific to 3D printing materials</li><li>Experience with AUTODESK FUSION 360 and CAD design software, part assemblies and modeling. </li></ul>#eligibleforerp MSJR NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $68,400.00 - $107,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Required Skills: Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills: Requisition ID:R292046

Specialist, Service Delivery/Management Development Engineering - GIO IT 3D Print RY (Hybrid - NJ)

Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Position Responsibilities:<ul><li>The Associate Director is responsible for performing comprehensive and detailed GMP compliance audits of human health sites, animal health sites, contractors, business partners, and suppliers.</li><li>Support new business opportunities through the performance of due diligence, pre-contract, and Pre-PAI audits.</li><li>Responsible for accepting audit assignments, performing audit pre-work, conducting audits, and write-up of audit reports within defined timeframes.</li><li>Maintain an understanding our company policies, procedures, and guidelines.</li><li>Maintain awareness of evolving industry and regulatory trends/regulations.</li><li>Obtain and maintaining auditor qualification through on-going training and continuing education programs to enable the performance of successful audits</li><li>Coordinate with Site Quality leads on audit refusals and postponements.</li><li>Lead project initiatives, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet site, management, and regulatory expectations</li></ul>Education Minimum Requirement and Experience:<ul><li>Bachelor's degree in science (BS) in Chemistry, (Micro-) Biology, Engineering (or equivalent) with ten (10) years' experience performing audits and/or quality operations experience. OR</li><li>Master's degree in science (MS) in Chemistry, (Micro-) Biology, Engineering (or equivalent) with eight (8) years' experience performing audits and/or quality operations experience.</li></ul>Required Experience and Skills:<ul><li>Must possess Subject Matter Expertise", including knowledge and demonstrated application in one or more of the following areas: Medical Device/Combination products, Biologics, Vaccines, API's, Non-sterile Drug Products, or Sterile Drug Product manufacturing. Biologics auditing experience is required.</li><li>Thorough understanding of Quality Management Systems and process to support the manufacturing of drug substances, drugs products, and medical devices.</li><li>Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.</li><li>Ability to work independently with limited supervision in a virtual-management environment.</li><li>Excellent communication, negotiation, influencing, and strategic thinking skills.</li><li>Review and approve audit reports (as assigned).</li><li>Must be detail oriented and organized.</li><li>Must be a positive change agent and able to adapt in a dynamic environment.</li><li>Must have the ability to travel globally approximately 50% of the time.</li></ul>Preferred Experience and Skills:<ul><li>Extensive experience auditing biologics and vaccine manufacturing sites.</li><li>External engagement in regulatory or industry forums.</li><li>Prior experience at a health authority performing GMP inspections.</li><li>Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.</li><li>Demonstrated ability to lead and drive results for business initiatives.</li><li>Demonstrated ability for process improvement.</li><li>Knowledge and expertise in application of Quality Risk Management pertaining to auditing, above-site function/processes, or technical areas.</li><li>Experience with development, implementation ,and optimization of IT tools to deliver business outcomes.</li></ul> Travel Expectation: <ul><li> Minimum 50% travel </li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Requisition ID:R292313

Associate Director, Quality Systems & Compliance

Job Description We are seeking applicants for an Associate Principal Scientist position available at the West Point, Pennsylvania research facility. The responsibilities of this role will be to lead and supervise a team of scientists to implement new-technologies, robotic systems, and develop automation solutions to enable vaccine process development, formulation development, vaccine investigations, vaccine characterization, and method lifecycle management. In this role, the individual must have strong analytical capabilities, ability to design, maintain, and implement robotic platform to support high-throughput and automated biochemical, immunological, and cell-based assays. The individual should have in-depth knowledge of hardware, proven troubleshooting abilities and programming experience with robotic liquid handlers as well as scheduling software across a range of platforms (Tecan, Hamilton, HighResBiosoutions). The individual should have in-depth knowledge of immune based, virology, and cell-based assay to supporting bioprocess development. Imaging and statistical analysis is considered a plus. As part of this role, the individual will author and review CMC sections of regulatory submissions and associated source technical reports and risk assessment documents. Previous experience working in a regulated environment, training, and leading lab scientists, transferring and qualifying assays would also be directly applicable. The successful candidate must function well, both independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment with proven leadership skills. Applicants must have effective organizational, multi-tasking, oral/written communications skills, show scientific leadership, and a desire to conduct research and publish. Additional responsibilities include leading a small group of technical personal and providing guidance to other scientists, evaluating new technologies, drive innovations to influence trends in industry, and preparing technical documents to support regulatory submissions. Evidence of strong cross-functional collaboration in bioprocess setting is also preferred. Education Minimum Requirement: <ul><li>A degree in Engineering, chemistry/biochemistry/ or related field plus industry experience is required: Ph.D. with a minimum of 4 years post-degree industry experience or M.S. with a minimum of 7 years or B.S. with a minimum of 10 years of experience in a related biotechnology field.</li></ul> Required experience and skills: <ul><li>In-depth knowledge and understanding of liquid handers, integrated robotic systems and software, and/or imaging methodology.</li><li>Proficiency in computer programming languages including Visual Basic, C#, MATLAB, Python and/or R.</li><li>Applied experience and knowledge with molecular biology, virology, and biochemistry techniques related to biologics or vaccines bioprocess. </li><li> In-depth knowledge of immune based, virology, and cell-based assay.</li><li>Experience training and leading junior scientists. </li><li>Knowledge of requirements in supporting health authority filings. </li><li>A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines.</li><li>Demonstrated scientific ability through publications and presentations in scientific conferences.</li></ul> Preferred Experience and Skills: <ul><li>Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications</li><li>Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP .</li><li>Ability to design, execute and/or direct development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development</li><li>Authoring and reviewing internal technical reports, sections of regulatory filings (e.g. IND, BLA) and external scientific publications.</li><li>Experience in representing analytical functional area on project teams.</li></ul>#AR&D #EligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: Hazardous Material(s): Requisition ID:R291874

Associate Principal Scientist, Vaccine Analytical R&D

Job Description Position Description: Associate Scientist, Chemistry The Analytical Development and Commercialization group currently have an exciting opportunity for an Associate Scientist at our West Point, PA site. In this role, you will be supporting formulation and process development for new drug products utilizing various analytical techniques. These supports include but are not limited to the following:<ul><li>Process and product characterization</li><li>Registration stability testing</li><li>Analytical method development and validation</li></ul>You'll have the opportunity to work with teams comprised of scientists and non-scientists to effectively coordinate efforts and track the progress for multiple projects. This position provides you with ample opportunities to keep abreast of innovative and novel scientific developments in the pharmaceutical industry by presenting your own work at meetings, attending seminars, and reading relevant literature. Position Qualifications : Education Minimum Requirement: <ul><li>BS/BA in chemistry or related scientific fields</li></ul>Required Experience and Skills: <ul><li>Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion</li><li>Familiar with common analytical instrumentation</li><li>Principled verbal written communications</li></ul>Preferred Experience and Skills:<ul><li>Experience with analytical techniques such HPLC, UPLC, UV, IR, Karl Fischer, and dissolution and ability in trouble shooting these methodologies</li><li>Experience with analytical work in the pharmaceutical industry, such as method development and validation</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement , all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. VETJOBS Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): N/A Requisition ID:R292467

Associate Scientist, Chemistry

Job Description As a Project Manager within the Strategy Realization Office (SRO) function of GMSA at our company, the successful applicant will play a critical role in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized internal management consulting team within Medical Operations, driving strategic, large-scale, cross-functional initiatives. Responsibilities:<ul><li>Support the SRO Lead in the execution of extensive, global initiatives, ensuring the program objectives and timelines are consistently met.</li><li>Facilitate the creation and approval of all project deliverables, including maintaining detailed Project Plans, Risk Plans, Issue Logs, and other control artifacts.</li><li>Serve as a key communication conduit, coordinating closely with Subject Matter Experts, stakeholders, Learning & Development, external vendors, and IT support teams.</li><li>Participate in SRO leadership activities, including strategic roadmap development, implementation planning, and change leadership.</li><li>Lead specific projects within the SRO, focusing on strategic planning, deliverables facilitation, timely communication, and project controls.</li><li>Prepare status reports as needed by the SRO and educate teams on specific business methodologies/tools laid down by the SRO.</li><li>Use approved SRO tools and techniques for managing your projects</li><li>Manage project finances and support communication needs.</li><li>Work within cross-functional teams to ensure alignment with project goals and program vision.</li><li>Support team leaders as a strategic thinker and tactical planner for process and technology solutions, timeline creation, resource assessment, risk management, Estimation, budget development, etc.</li><li>Communicate and escalate issues, challenges, and risks to executive management, team leaders, and SRO leadership as required in a timely manner.</li></ul> Minimum Qualifications: Education:<ul><li>Undergraduate (BS) degree and a minimum of 10 years relevant experience, or a MS Degree and 8 years of experience.</li></ul>Skills & Qualifications:<ul><li>10+ years' experience in project management working with cross functional teams across multiple geographies and functions.</li><li>Exposure to Medical Affairs function within a reputed Pharma would be a plus</li><li>Strong strategic thinking, planning, and leadership skills.</li><li>Demonstrated expertise in managing large-scale, cross-functional initiatives.</li><li>Expertise in process improvement, enabling technology solutions, organizational design, compliance, change management and other related areas.</li><li>Excellent communication skills, with the ability to liaise effectively with a range of stakeholders.</li><li>Highly developed problem-solving skills, with the ability to anticipate and manage project risks and issues.</li><li>Strong financial management skills, with prior experience managing project finances.</li><li>International experience in managing projects in a global company, with exposure to diverse cultures and working environments</li><li>Exceptional project management skills, including effective communication (both oral and written), facilitation, negotiation/conflict resolution, and resource management abilities</li><li>Proven self-starting and follow-up ability, with a strong sense of responsibility and ownership for projects</li><li>Excellent people skills, with the ability to lead and inspire teams, build strong relationships with executives, and effectively collaborate with cross-functional stakeholders</li><li>Extensive experience in matrixed organizations, with the ability to lead and influence teams and stakeholders across different functions and geographical locations</li><li>Strong problem-solving and analytical skills, with the ability to identify and address project issues and risks proactively</li><li>Proficient in managing project requirements for global initiatives, with experience in defining and tracking deliverables across multiple countries and locations</li><li>Advanced proficiency in MS Project, Excel, Word, Visio, and PowerPoint</li><li>Demonstrable understanding of change management principles and practices, with experience in managing and driving change within project initiatives</li><li>Willingness to travel to international and domestic sites as required, to oversee project execution and collaborate with stakeholders</li><li>Previous experience in successfully managing projects with multi-location, multi-country teams</li></ul>Preferred Experience and Skills:<ul><li>Knowledge of the pharmaceutical/Life Sciences industry, including an understanding of regulatory requirements and industry trends</li><li>Experience as a consultant, preferably with a background in management consulting, providing strategic guidance and support to clients</li><li>Project management certification (PMP/PgMP), demonstrating a strong foundation in project management best practices</li><li>Experience working in an Agile environment, or managing projects using Agile methodologies and frameworks</li><li>Previous involvement in at least one global transformation project, overseeing organizational change initiatives on a global scale</li><li>This role offers a unique opportunity to drive impactful initiatives within Global Medical and Scientific Affairs, contributing to the continuous improvement of our Medical Affairs practices at our company. As part of the SRO team, you will have the chance to work closely with various teams and be part of a significant strategic journey.</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $122,800.00 - $193,300.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Requisition ID:R292517

Associate Director, Medical Affairs - Program Management

Job Description The Business Platform lead in the Platform Team plays a crucial role in analyzing business requirements, facilitating communication between stakeholders, and ensuring the successful implementation of platform solutions. This role will collaborate closely with the platform team, product managers, developers, and various business units to gather, refine, and document requirements. They will also actively participate in the design and development of platform solutions to meet the evolving needs of the organization. Responsibilities: <ul><li>Requirement Gathering and Analysis:<ul><li>Conduct thorough analysis of business needs and translate them into detailed requirements and user stories.</li><li>Collaborate with stakeholders to define clear business objectives, functional requirements, and acceptance criteria.</li><li>Identify and document any gaps or inconsistencies in requirements, and propose appropriate solutions.</li><li>Conduct stakeholder interviews and workshops to elicit requirements and prioritize them based on business value.</li></ul></li><li>Documentation and Communication:<ul><li>Prepare clear, concise, and thorough documentation such as business requirement documents, functional specification documents, and process flow diagrams.</li><li>Communicate effectively with technical and non-technical stakeholders to ensure a shared understanding of requirements and project vision.</li><li>Facilitate effective communication and collaboration within the platform team and with other teams across the organization.</li></ul></li><li>Solution Design and Validation:<ul><li>Collaborate with architects, developers, and UX designers to translate requirements into solution designs.</li><li>Participate in solution validation by reviewing prototypes and conducting user acceptance testing.</li><li>Identify and address any usability, scalability, or performance concerns during the design phase.</li></ul></li><li>Project and Product Management:<ul><li>Assist product managers in defining user stories, prioritizing backlogs, and managing product roadmaps.</li><li>Collaborate with project managers to estimate effort, manage scope, and ensure timely delivery of platform solutions.</li><li>Contribute to the continuous improvement of project management and software development processes.</li></ul></li><li>Stakeholder Management:<ul><li>Build and maintain strong relationships with stakeholders to understand their needs, expectations, and pain points.</li><li>Manage stakeholder feedback and prioritize their requirements based on business impact.</li><li>Provide regular updates to stakeholders on project progress, risks, and mitigation plans.</li></ul></li></ul> Education: <ul><li>Bachelor's degree in science, Engineering, Computer Science, Health Care or related field</li></ul> Experience/Skills: <ul><li>At least five (5) years of experience implementing platform solutions required.</li><li>At Least five (5) Experience gathering and analyzing business requirements and facilitating communication between stakeholders required.</li><li>Strong analytical and problem-solving skills, with the ability to think critically and strategically.</li><li>Excellent interpersonal and communication skills, with the ability to effectively collaborate with diverse stakeholders.</li><li>Solid understanding of software development processes and methodologies.</li><li>Ability to work collaboratively in cross-functional teams to achieve milestone and goals.</li><li>Proficiency in requirements management tools and techniques.</li><li>Knowledge of agile methodologies such as Scrum or Kanban.</li><li>Tools: Application Lifecycle Suite, Microsoft Word, PowerPoint, & Database knowledge, JIRA & Confluence.</li><li>Experience in software development lifecycle processes (SDLC), in pharmaceutical industry or any regulated industry will be desirable.</li><li>Clinical systems knowledge highly preferred.</li></ul>#EligibleforERP MRLGCTO #ONEGDMS NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $111,400.00 - $175,300.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): No Requisition ID:R288981

Business Platform Lead (Hybrid)

Job Description This position will have multiple openings that will cover Western (Pacific time), Central, and Eastern time zones. Summary of the Job: Our Account Representatives interact with our customers virtually, understand their needs, and consult to offer the right solutions within our Canine and Feline product portfolios. We work collaboratively as a team and play a critical role in supporting our customer centric business model. This position is responsible for working with accounts in their respective territory to understand and identify veterinary clinic, shelter facility, and corporate account customer needs, by selling our Company's Animal Health (AH) division products, supporting pull-through activities relative to the customer strategy, and ensuring that our Company's Animal Health division is viewed as bringing value and technical innovations aligned to our strategic focus - The Science of Healthier Animals. In addition, the Account Representative demonstrates an understanding of the resources available across our Company's Animal Health division and our Distribution Partners. Essential Accountabilities:<ul><li>Demonstrates an ability to quickly connect and build rapport.</li><li>Ability to thrive in a digital environment using MS Office, MS Teams, Outlook and Salesforce.</li><li>Primary point of contact for assigned customers, connect with key personnel/decision makers to understand practice structure, business model, key influencers (Owner/Practice Manager/Key Tech/Associate Vet/Front office staff), customer needs and identifies business opportunities.</li><li>Develop customer strategy - outlining strategy for interactions/relationship, solutions, partner involvement and potential offerings for customer resulting in sales opportunities and account sales growth of Animal Health products and services.</li><li>Develop territory and specific account plans for all key customers. Partners with National Account Managers, Corporate Account Team, and Distribution Partners to maintain strong focus on key accounts and corporate owned clinics to drive occupancy and sales growth.</li><li>Work collaboratively across all species teams to foster our Company's approach to enhance knowledge of the entire Animal Health product portfolio.</li><li>Shares with other team members within the region to foster growth and development within the team.</li><li>Analyze sales results on a monthly basis and manage expenses within budget guidelines.</li><li>Identifies and selects programs/services available within Animal Health's available resources to address customer needs and provide education & training opportunities to accounts.</li><li>Works with leadership and Professional Services to develop and deliver relevant offerings that address desired customer needs.</li><li>Develop current understanding of Animal Health products, industry trends and competitor landscape.</li><li>Develop knowledge of our omni-channel demand generation tools and how to leverage these tools to drive positive outcomes.</li><li>Articulates and communicates relevant customer, industry, product, and market trends appropriately through the organization.</li><li>Responsible for developing and meeting learning and development objectives agreed upon with leadership.</li></ul>Scope and Context:<ul><li>This position is an individual contributor role.</li></ul>Animal Health Commercial Competencies Leadership Behaviors<ul><li>Demonstrate Ethics & Integrity</li><li>Drive Results</li><li>Focus on Customers & Patients</li><li>Make Rapid Disciplined Decisions</li><li>Act with Courage & Candor</li><li>Build Talent</li><li>Foster Collaboration</li></ul>Professional Competencies <ul><li>Business & Financial Acumen</li><li>Working Across Boundaries</li><li>Strategic Thinking</li><li>Productive Communication</li><li>Problem Solving</li><li>Project Management</li></ul>Core Commercial Functional Competencies <ul><li>Customer and Market Insights</li><li>Product Knowledge & Portfolio Management</li><li>Account Management</li><li>Customer Engagement</li><li>Market Access</li><li>Regulatory & Compliance Knowledge</li><li>Lifecycle Management</li></ul>Minimum Qualifications: Required Skills/Abilities:<ul><li>Excellent interpersonal/communication and presentation skills</li><li>Demonstrated motivation and focus on achieving measurable, tangible results.</li><li>Commitment to collaboration as the normal mode of working and resolving problems.</li><li>Demonstrated understanding of positions' contribution to the business goals and willingness to adopt changes to current processes to meet customer needs.</li><li>Demonstrated ability to independently understand customers' evolving needs and expectations and combines with knowledge of customers' organization and culture to drive results.</li><li>Effective application of selling techniques and approaches, simultaneously managing multiple customers/accounts at different stages of the sales process, articulating the value of Animal Health products using approved resources.</li><li>Demonstrated ability to identify, develop and manage a diverse mix of accounts independently within a territory, including some complex accounts, and to develop plans based on unique opportunities and customer needs.</li><li>Proficient computer skills including working knowledge of Word, Excel and PowerPoint and the ability to use an iPad.</li><li>Ability to work independently and also as part of a team</li><li>Ability to travel for sales meetings, trainings, and other business needs</li></ul>Preferred Skills/Abilities Background & Education:<ul><li>Bachelor's Degree preferred.</li><li>Sales experience and/or experience within the Animal Health industry</li><li>Experience selling animal health products is preferred.</li><li>Knowledge of animal health biological and pharmaceutical products.</li><li>Understanding or past experience working with distribution.</li><li>Multi-lingual fluency preferred, particularly in Spanish.</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $62,000.00 - $97,600.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: No Hazardous Material(s): NA Requisition ID:R292491

Inside Sales Account Representative - Companion Animal (Remote)

Job Description The incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing various GMP activities supporting the production of clinical supplies with focus on drug product. Additionally, experience in medical device and/or combination products would be preferred. Key activities that this position would be responsible for include: leading internal contractor related issue investigation and resolution teams, review and approval of contractor-initiated investigations associated with deviations, negotiation of site and global Technical and Quality Agreements, maintenance and accuracy of the Development Approved Vendor Listing, participating in contractor GMP audits as a Subject Matter Expert, development and creation of contractor related metrics, conduct of contractor deep dive" quality assessments such in data integrity and leading cross-functional contractor performance reviews as the quality lead for the oversight platform. The position will be heavily involved in close collaboration with the contractor quality and technical personnel and interacting with their functional equivalents in Quality Disposition and Pharmaceutical Research and Development and, Procurement on strategic objectives utilizing external contractors including GMP qualification as well as site/project selection. Additionally, the incumbent would serve as the bridge between R&D and Commercialization activities and develop a strong working relationship with commercial external quality management personnel. The incumbents would be the key quality representatives attending and contributing at oversight and business review meetings with our Company and contractor personnel to discuss projects, financial, operational/quality and overall performance topics. In addition to the job specific responsibilities discussed above, the incumbents are expected to independently execute on the following:<ul><li>Plans and facilitates high risk and highly complex Quality-related process reviews and/or investigations under minimal supervision.</li><li>Provides project leadership in area of expertise in own discipline (such as leading or facilitating teams involving source area representatives in a matrix management environment).</li><li>Leads Quality-related reviews, cross-functional process teams and/ or investigations, serving as a subject matter expert.</li><li>Engages in strategic planning activities across the Quality Unit and directly responsible for project planning and activities of self and indirect reports associated with team activities.</li><li>Makes independent decisions and acts with authority to carry out required actions.</li><li>Coaches, mentors and develops colleagues in areas of expertise. Leads others in a matrix/management environment.</li><li>Lead the resolution of business practice, Quality and/ or compliance issues of broad scope and highest level of complexity. on cross-functional and/ or cross-divisional basis.</li><li>Identifies trends and/or potential compliance gaps and proactively leads the resolution of long-standing or significant issues affecting quality and efficiency.</li><li>Leads communication, and serves as Quality spokesperson, on a variety of Quality or compliance-related issues.</li><li>Interprets complex regulatory requirements for various audiences, including source area management, and facilitates communication of these requirements across stakeholders. Reviews draft policy and standards.</li><li>Communicates with senior management within our Company and the contractor organization. Facilitates and/or prepares cross-functional management presentations.</li><li>Identifies and leads implementation of Contractor and Supplier System improvements.</li></ul>Education:<ul><li>Minimum of a Bachelor's degree in relevant area.</li></ul>Experience:<ul><li>Minimum of 5 years within pharmaceutical drug product manufacturing and 10 years overall within biopharmaceuticals.</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. GRACSJOBS Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $122,800.00 - $193,300.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Requisition ID:R292703

Associate Director, Third Party Quality Management Drug Product (Hybrid)

Job Description Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new Oncology medicines within an Asset team. Our Company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Senior Director may be responsible for: <ul><li>Providing scientific and medical leadership for strategic alliances and Co-partnership opportunities. </li><li>Supporting the team in prioritizing external collaborations. Recognize and capitalize on opportunities to adapt direction in light of project successes and failures and market changes. </li><li>Managing selected opportunities, developing strategy and detailed milestones, measures, timelines and budgets to achieve designated value inflection points. </li><li>Identifying, negotiating and maintaining critical external partnerships. </li><li>Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications; </li><li>Developing clinical development strategies for investigational or marketed Oncology drugs </li><li>Planning clinical trials (design, operational plans, settings) based on these clinical development strategies </li><li>Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs; </li><li>Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and</li><li>Participating in internal and joint internal/external research project teams relevant to the development of new compounds and combinations of these with marketed compounds. </li></ul> In executing these duties, the Senior Director may: <ul><li>Supervise the activities of Clinical Scientists in the execution of clinical studies</li><li>Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and</li><li>Assist the Executive Director/Associate Vice President in ensuring that appropriate corporate personnel are informed of the progress of studies of our company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility. </li></ul> The Senior Director is responsible for maintaining a strong scientific fund of knowledge by: <ul><li>Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies </li><li>Identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs </li><li>Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs </li><li>Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility. </li></ul> To accomplish these goals, the Senior Director may: <ul><li>Author detailed development documents, presentations, budgets, and position papers for internal and external audiences</li><li>Manage a complex matrix of internal stakeholders within clinical development (i.e. across existing PDTs and TAs) and across functions </li><li>Facilitate collaborations with external researchers around the world </li><li>Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects. </li></ul> Education: <ul><li>Required: M.D or M.D./PhD combination</li><li>Board Certified or Eligible in Medical Oncology (and/or Hematology), Radiation Oncology, Surgical Oncology or a related discipline is preferred. An equivalent combination of training and experience will be considered. </li></ul> Required: <ul><li>Must have experience in industry or senior faculty in academia</li><li>Minimum of 3 years of clinical medicine experience</li><li>Minimum of 1 year of industry experience in drug development or biomedical research experience in academia</li><li>Demonstrated record of scientific scholarship and achievement</li><li>A proven track record in clinical medicine and background in biomedical research</li><li>Strong interpersonal skills, as well as the ability to function in a team environment are essential.</li><li>High level of verbal and written communication, including presentation skills.</li><li>Strong learning agility and growth mindset</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $268,500.00 - $422,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Requisition ID:R289377

Senior Medical Director,  Oncology Asset Development Team

Job Description Our Company's Information Technology division partners with colleagues across the business to help serve our patients and customers around the world. Ours is a high-energy team of dynamic, innovative individuals dedicated to leveraging information and technology to efficiently drive revenue and productivity, thereby advancing our company's contribution to global medical innovation. Enterprise IT (EIT) is an essential component of the current IT division that provides support to the Pharmaceutical Research, Supply Chain, Marketing organizations as well as Enabling Functions. The EIT SAP Platform Team is responsible for our company's SAP Global Template asset, delivering enterprise-level capabilities through harmonized business processes and data. The team is responsible for the operation of all SAP and integrated solutions, governance of the associated enterprise assets, and cost-effective delivery of capabilities to support achievement of immediate and future state business objectives. Within the EIT SAP Platform Team, the SAP FI/CO Technical Lead will focus on preserving the continuity of our Company's Finance applications. The candidate will provide functional design and guidance for the Finance Business Management (FBM) processes and manage end-to-end SAP technical configuration for the SAP FI/CO modules. This role reports to the Global Financial Business Management Director. Responsibilities: Leadership and Management: <ul><li> Lead a global team of 6-8 functional resources-combination of employees and contractors. Responsible for delivery and governance of SAP Financial applications and reporting: FI-General Ledger, Controlling: CCA, PCA, IO, CO-PA). Familiarity with SAP Project Systems (PS) helpful. </li><li> Foster a culture of excellence, collaboration, and continuous improvement within the team. </li><li> Provide mentoring, coaching, and professional development opportunities to team members. </li></ul> SAP Cross-Functional Delivery: <ul><li> Collaborate with delivery peers to ensure best-in-class delivery from solutioning of business requirements through unit-tested, working solutions. </li><li> Collaborate with the Finance and Procurement Value Teams around aligned prioritization and delivery commitments. </li></ul> SAP Functional Expertise: <ul><li>This role will be the Subject Matter Expert in the SAP FI/CO modules of SAP and is responsible to sustain the ERP FBM solutions to support our Company's Human Health business.</li><li>Ensure appropriate integration of processes across the organization.</li><li>Accountable for providing overall direction to the support team. Communicates/coordinates across business and IT to resolve critical incidents resulting in significant impact to business operations and finance month end close.</li><li>Provide functional leadership and guidance to the SAP team and business users in optimizing business processes within the SAP environment.</li><li>Stay up to date with the latest developments in SAP functionality and identify opportunities for process improvements and automation.</li><li>Ability to visualize end-to-end integrated business processes and impacts across key areas such as Financial Business Management, Order to Cash, Source to Settle, Supply Chain Management, Tax, and Financial Supply Chain.</li></ul>SAP Configuration:<ul><li>Responsible for SAP configuration changes and developments align with business requirements, industry standards, and regulatory compliance.</li><li>Adhere to change control processes and methodologies to minimize system disruptions and ensure system stability.</li><li>Collaborate with cross-functional and technical teams to prioritize and work independently on the delivery of SAP enhancements and new functionalities.</li></ul>Stakeholder Collaboration:<ul><li>Collaborate closely with Business Process Stewards, Global Enterprise IT/ERP Operations functional/technical leads to understand business requirements and translate them into effective SAP solutions. </li><li>Work closely with Value team to prioritize, providing insights and recommendations on leveraging SAP capabilities to drive business growth and operational excellence.</li></ul> Required Education Level: <ul><li> Bachelor's Degree required in Accounting, Finance, Business, IT or similar area. </li><li> Advanced Degree is a plus. </li></ul> Required Skills & Experience: <ul><li> Minimum 3-5 years' experience in SAP FI/CO modules of SAP. Familiarity with SAP Project Systems (PS) helpful. </li><li> Full life cycle implementation and supporting Finance Shared Services experience would be a plus. </li><li> Experience in SAP HANA S/4 environment preferred. </li><li> SAP delivery team leadership experience required. </li><li> Adept at understanding internal customer challenges, navigating from problem to resolution and communicating the resolution effectively, both verbally and in writing. </li><li> Ability to multitask and manage multiple deliverables and projects at the same time. </li><li> Life Sciences Industry experience preferred. </li><li> Cross-functional business process experience required. </li><li> Experience working in a collaborative, matrixed environment preferred. </li><li> Proven record of excellent performance </li><li> Proficiency with project management tools. </li><li> Strong interpersonal skills: the ability to work well with people from different disciplines with varying degrees of technical experience; competence in clear concise and tactful communication with senior management, clients, peers and team members. </li></ul> Travel Requirements: 10-15% annually. Candidates based in PA will be required to travel to Rahway, NJ at least once per week. #eligibleforerp NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $135,500.00 - $213,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Required Skills: SAP Controlling (CO), SAP FICO Configuration, SAP FICO Implementation Preferred Skills: Requisition ID:R283480

Associate Director, Financial Business Management (FBM) Technical Lead - (Hybrid - NJ or PA)

Job Description Global Project and Alliance Management (GPAM) resides within the Research and Development (R&D) organization at our company (our company's Research Laboratories). The Project, Portfolio and Alliance Managers in GPAM are core members of cross-functional discovery, development, and alliance teams responsible for discovering and developing products that improve human health. In addition, GPAM includes a Project Management Office (PMO), which is responsible for the development, sustainment, and training of GPAM-owned systems, tools, and business processes that serve our company's Research Laboratories more broadly. The GPAM our company's Research Laboratories Alliance Managers focus on achieving the goals of the alliance by ensuring activities, resources, communications, and decisions are coordinated and maximized with our Research & Development partners. Position Description/Summary: Under the broad direction of the Senior Director or Director, Strategic Alliances, the Associate Director, Strategic Alliances is responsible for ensuring successful relationship and contractual management of Research & Development licenses and Research & Development alliances/collaborations that result from agreements executed by Corporate Business Development (Corp BD). Responsibility includes engaging internal and partner leaders at all levels to maximally leverage assigned Research & Development stage alliances for both our company and its Research & Development partners. This position may be based in either Rahway NJ, Upper Gwynedd PA, Boston MA, or San Francisco CA. Primary Responsibilities:<ul><li>Participate in potential partner due diligence and/or late-stage negotiations to assess cultural fit, ensure understanding of strategic/critical issues, and provide input into governance/decision-making rights and relevant operational aspects of the agreement.</li><li>Take responsibility for organization of timely and seamless implementation of new alliances at the internal and joint team/governance committee levels through comprehensive kick-off meeting planning and execution.</li><li>Identify and align key stakeholders across internal and partner functions. Ensure alliance governance is established and functions efficiently, consistent with agreement intent. Enables joint research and development activities and timely decision-making, considering necessary linkages to our company's senior management/governance mechanisms.</li><li>Proactively identify and resolve conflicts as needed or raise conflicts and dispute to appropriate management or committees for timely resolution.</li><li>Facilitate, manage, and oversee the scientific and operational relationship between our company and assigned alliance partners to ensure a productive working environment.</li><li>Provide to each alliance partner an open and continuous channel of communication to ensure partner perspectives are heard and well represented internally.</li><li>Interface closely with the Corp BD and Transaction Legal groups to clarify contractual aspects of collaboration agreements with intent of providing guidance internally to team, committee members and senior management to enhance the value of alliances, ensure appropriate boundaries are set and guide decision-making.</li><li>Support evolution of alliances through their life cycles, including negotiation/drafting of contractual amendments, through management of any necessary agreement terminations.</li><li>Work closely with Finance, Investor Relation, Public Affairs and partners to manage appropriate financial obligations / disclosures material to our company and/or its partners.</li><li>Contribute to goal of establishing our company's Research Laboratories Alliance Management as a learning organization by sharing lessons learned and best practices in alliance management within and across divisional alliance management areas.</li><li>Become our internal expert on the partner company by building a deep understanding of the company's organization/leadership, strategies, financials, priorities, etc.</li><li>Participate in relevant partnering and/or Alliance Management conferences to represent our company's Alliance Management, contribute to securing our company's reputation as a Partner of Choice and identify external best practices for internalization.</li></ul>Education Minimum Requirement:<ul><li>Bachelor's degree required; concentration in a scientific or applied discipline preferred.</li></ul>Required Experience and Skills:<ul><li>A minimum of 8 years' experience in the biotech/pharmaceutical industry</li><li>A minimum of 1 years in an engagement and/or alliance manager role or equivalent relationship management role</li><li>Broad understanding of global pharmaceutical and biotech industries with a solid understanding of drug discovery and development processes.</li><li>Superior interpersonal skills and expert team player with ability to build and manage collaborative relationships at all levels inside and outside of the organization, specifically with senior management.</li><li>Demonstrated leadership and ethics, including ability to hold others accountable for delivery.</li><li>Demonstrated ability to work effectively in a team setting, including experience building and leading teams, accomplishing goals, etc.</li><li>Strong collaboration and problem-solving skills; ability to establish good working relationships with internal and external colleagues at all levels, resolve conflict and provide feedback, and devise and implement creative solutions to problems.</li><li>Strong communication skills, both oral and written; demonstrated ability to speak up appropriately and to raise issues to teams and management.</li><li>Highly organized and capable of working with attention to detail. Able to relate project and alliance details to larger project and alliance objectives.</li></ul>Preferred Experience and Skills:<ul><li>Advanced degree (MBA, MS, PhD or equivalent)</li><li>Experience in understanding and interpretation of contractual language.</li></ul>Required Travel:<ul><li>Yes, up to 25%</li></ul>GPAMjobs eligibleforERP VETJOBS #EBRG NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $135,500.00 - $213,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Requisition ID:R287315

Associate Director, Strategic Alliances- Hybrid

Job Description Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed in alignment with our incredibly high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Line Oversight Program at West Point focuses on early career talent development providing hands-on experience in pharmaceutical quality assurance supporting our Company's largest and most complex vaccine manufacturing plant site. This program also supports opportunities to further learn, upskill, and network within different parts of the business outside of the primary responsibilities for career development purposes. The targeted start date for this position will be in the spring, summer, and/or fall of 2024. The position will be a direct manufacturing support role primarily on the shop floor within our Quality Line Oversight team. This team rotates through the vaccine filling and packaging departments at the West Point site providing quality and compliance oversight to our 24/7 manufacturing operations. Primary responsibilities involve:<ul><li>Quality checks of finished product including visual inspection of vials, syringes and packages</li><li>Verification of appropriate line clearance between batches to prevent product mix-ups</li><li>GMP document / batch record review</li></ul>Additional responsibilities include:<ul><li>Internal/external audit support</li><li>Continuous improvement projects by partnering with Operations, Technology, and/or other Quality groups in areas such as safety, quality, and efficiency</li></ul>The shift structure for the position includes 12-hour day and night shifts which rotate approximately every two months. The position does require weekend coverage. This is an entry level position, and 0-2 years of experience in pharmaceutical industry through internships, co-operative education or other roles is preferred. GENERAL PROFILE:<ul><li>Contributes to the performance and results of a vaccine manufacturing department.</li><li>Provides regulatory, quality and compliance guidance.</li></ul>BUSINESS EXPERTISE:<ul><li>Applies technical, collaboration and interpersonal skills to align activities with department objectives.</li></ul>FUNCTIONAL EXPERTISE:<ul><li>Works as a team member on shop floor core tasks, quality systems activities and/or process improvement projects.</li><li>Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.</li><li>Assures consistent application of standardized work, process tools, and procedures.</li><li>Assists with regulatory inspections in either documentation area, request management area or inspection room.</li><li>Provides quality guidance to technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.</li><li>Effectively collaborates with peers on site and above site as required.</li></ul>Education Minimum Requirement: <ul><li>Bachelor's Degree in Engineering or Sciences</li></ul>Required Experience and Skills: <ul><li>Willing to work alternate shifts and weekends</li><li>Ability to focus on and obtain results</li><li>Good verbal and written communication skills</li><li>Ability to effectively collaborate within and across an integrated manufacturing team</li><li>Ability to enact conflict resolution</li><li>Ability to effectively respond to change</li><li>Excellent analytical and organizational skills</li><li>High personal integrity, credibility and energy</li><li>Flexibility to perform related tasks to support the business</li><li>Computer literacy in MS Office, Word, Outlook, Excel</li></ul>Preferred Experience and Skills:<ul><li>0-2 years working experience in cGMP pharmaceutical environment</li><li>Experience using Lean/Six Sigma tools</li></ul>Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. Who we are ... We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for ... Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. MMD2024 FTP2024 ETJobs Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day, 2nd - Evening, 3rd - Night Valid Driving License: No Hazardous Material(s): NA Requisition ID:R241186

2024 University Recruiting - West Point Quality Line Oversight Program - 2024

Job Description Position Description: Senior Scientist (Early Clinical Scientist) The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials with the Clinical Director, and internal/external team members. Oversees trials within and/or across program(s)/therapeutic areas and ensures excellence in execution/compliance to support study objectives and data validity. Manages internal/external team performance to achieve project objectives and resolves project performance issues if they arise. Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development. Represents Early Stage Development on cross-functional teams to develop and/or improve internal job aids/SOP/clinical development procedures. Identifies and communicates best practices within the organization. Promotes departmental adaptation of new procedures. Technical Writing & Communications Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. Ensures documents are completed in accordance with applicable standards. Develops study operational documents with input from team members (e.g. site monitoring plan, study operations manual, informed consent, etc.). Project Management Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines. Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes/procedures. Position Qualifications : Education Minimum Requirement: <ul><li>Degree in Life Sciences &bull;</li><li>Bachelor's degree and ≥7 years related* experience OR &bull;</li><li>Master's degree and ≥5 years related* experience OR &bull;</li><li>PhD or doctorate degree and ≥1 year related* experience &bull;</li><li>*e.g., knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing; OR</li><li>equivalent experience with developing preclinical model experiments for drug candidates (protocol authoring, experiment execution/oversight, authoring experiment reports).</li></ul>Required Experience and Skills: <ul><li>Understanding of clinical research development process from program planning to regulatory submission &bull;</li><li>Able to quickly develop a working scientific knowledge of different therapeutic areas &bull;</li><li>Ability to manage complex operations and projects under accelerated timelines &bull;</li><li>Scientific, medical and/or safety writing and reporting (at least one is required) &bull;</li><li>Ability to partner effectively with internal and external teams to achieve results &bull;</li><li>Strong team collaboration, leadership, communication (written & verbal), issue identification and resolution skills &bull;</li><li>Knowledge of GCP, ICH guidelines and regulatory requirements &bull;</li></ul>Preferred Experience and Skills: <ul><li>Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience a plus.</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $125,000.00 - $196,800.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Requisition ID:R281611

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