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Job Description The Global Regulatory Policy & Intelligence (GRPI) team advocates for regulatory policy that supports our company's business goals, developing wider support for our causes and maintaining a strong reputation as a science-led biopharmaceutical leader. We work in partnership with the company's Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to define and implement a prioritized plan for policy that advances business goals. Our GRPI team responsibilities include:<ul><li>Developing and delivering world-class regulatory policy service for all business segments and regions.</li><li>Proposing - and responding to - regulatory guidance and action.</li><li>Advocating for and anticipating regulatory change with globally leading regulators and multilateral organizations.</li><li>Providing insights and advocating for positions on critical regulatory issues and trends.</li><li>Building our company's share of voice and influence extramurally to support the company's enterprise policy agenda.</li></ul>Responsibilities of the Director, US Regulatory Policy, will include:<ul><li>Proactively monitoring emerging scientific and regulatory trends/strategies, both internally and externally, to shape and influence changes in the global regulatory environment. </li><li>Serving as subject matter expert in FDA internal practices and external policies , regulatory processes, laws, and regulations, for assigned areas, with a strong knowledge of how regulatory policy is shaped and developed in the United States.</li><li>Representing the company in assigned areas on industry committees, with agility to cover areas outside those assigned as needed and/or as pipeline needs change.</li><li>Maintaining productive relationships with industry staff and global regulators to ensure productive Agency interactions; fostering internal relationships to ensure company needs can be gauged and understood to facilitate both external advocacy and internal implementation.</li><li>Planning and managing GRPI interactions with our Research and Development Division's colleagues, regulatory liaison staff, and local regulatory affairs staff for submission of product applications and other related interactions with Health authorities.</li><li>Monitoring emerging regulatory policy issues in assigned areas, including issues arising from global regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identifying those issues likely to impact the company's regulatory strategy or product portfolio.</li><li>Leading internal teams as assigned to address regulatory policy issues. Assignments will evolve over time to meet business objectives and programmatic needs, and Director's areas of expertise.</li><li>Coordinating appropriate internal staff to develop company responses to draft legislation, regulations, guidance, and other regulatory policy documents.</li><li>Planning and managing interactions and communications with trade associations and health authorities on regulatory policy matters.</li><li>Participating in regulatory project teams to help develop regulatory strategies based on knowledge of FDA requirements, guidance, policies, and procedures.</li><li>Participating in regulatory staff meetings to learn about product matters likely to surface which may require involvement/action of the GRPI staff.</li><li>Managing activities for select meetings with FDA and other health authorities (e.g., regulatory milestone meetings, management meet and greets", ad hoc policy-focused meetings) as assigned for specific projects. </li><li>Maintaining liaison with outside scientific and professional organizations to represent the company on product and regulatory policy matters under the supervision of the Executive Director, US Lead, US Regulatory Policy.</li><li>Participating in industry and professional meetings to maintain competency on regulatory policy issues.</li><li>Participating in industry and professional meetings to actively advocate for company-specific or Industry-wide issues.</li></ul>Education Requirement:<ul><li>Bachelor's Degree is required, preferably in science, health care, public health or health policy or BS in any field accompanied by a Master's or Doctorate degree in science, health care, public health, health policy, or law</li><li>Doctorate degree and at least 5 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority) OR</li><li>Master's degree and at least 8 years' experience with FDA or other health authority, either directory (working within a health authority) or indirectly (closely interacting with health authority) OR</li><li>Bachelor's degree and at least 10 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority)</li></ul>Qualifications Required:<ul><li>Proven capability in acting as a credible, influential and respected spokesperson able to convey complex messages, trends & insight</li><li>Deep understanding of the US regulatory environment, the Food, Drug and Cosmetic Act and latest regulations and guidance's with sound knowledge of intelligence tools and methods; preference will be given to candidates with experience supporting therapeutic product applications and submissions to health authorities, or similar background in regulatory strategy .</li><li>Strong relationship management and interpersonal skills with superb written and oral and communication skill</li><li>Proven success at stakeholder engagement across organizational levels and boundaries with ability to manage highly complex situations and engender trust when dealing with sensitive issues</li><li>Ability to fully demonstrate our company leadership principles, driving results and building talent.</li><li>Ability to thrive in a cross-functional team environment with a global mindset</li><li>Ability to travel internationally</li><li>Excellent command of English (written and spoken)</li></ul> #JoinResearchLabs 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: Valid Driving License: Yes Hazardous Material(s): Job Posting End Date: 05/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293393

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Director, Global Regulatory Policy - US

Job Description Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 130-year legacy. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. We know that our people are the key to our success, which is why this team works to attract, develop, retain and inspire our people so that they can learn, grow and make a true impact on the world. Together we collaborate to create a culturally rich, diverse organization ensuring we remain innovative and agile. We are looking for an energetic professional to join our Enterprise Information Technology team to help us identify and deliver business solutions, in partnership with our company's Finance and Information Technology colleagues, to our most critical organizational and people management functions across the company leveraging the advanced cloud-based solutions in the technology marketplace. This candidate will be critical to helping us shift to modern ways of working to accelerate the execution of our strategy to increase flexibility, accelerate time-to-market of solutions, and drive significant business value. As a Product/Business Analyst within the IT group, you will:<ul><li>Establish and maintain relationships with global Finance and IT colleagues to help accelerate the delivery of our business solutions.</li><li>Gain a deep understanding of the Finance business processes, systems, and data that support strategic processes and programs related to financial close, consolidation, and external reporting.</li><li>Develop an understanding of the various technology solutions that can be applied to requirements.</li><li>Actively participate and collaborate on the technical implementation of key applications to help ensure alignment between business needs and solutions.</li><li>Demonstrate the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.</li><li>Demonstrate skill in using an open communication style that actively acknowledges other thoughts and opinions.</li><li>Demonstrate ability to independently solve problems that arise within job responsibility and expectations.</li><li>Share best practices, tools, and techniques across product teams.</li><li>Partner with our vendors to ensure optimal solutions and to enhance the capabilities of their products to improve overall value provided.</li><li>Be part of agile teams and collectively work towards common goals.</li><li>Able to succeed in a dynamic, rapidly changing, highly matrixed business environment.</li></ul>Key Responsibilities:<ul><li>Gain deep subject-matter expertise on the finance business process to manage sales, inventory, and product cost data as it relates to the calculation and reconciliation of Intercompany Profit.</li><li>Gather and document business process and business / user needs to support the implementation of software products and/or services</li><li>Partner with business stakeholders on the development business cases to support the justification for undertaking a project, program or portfolio, including the benefit, cost and risk of alternative options, and rationale for the preferred solution.</li><li>Assist with the prioritization of IT backlog in support of the finance business process to manage sales, inventory, and product cost data as it relates to the calculation and reconciliation of Intercompany Profit.</li><li>Lead the planning, designing, and assist the business on the coordination of testing activities and business change management, as part of overall solution implementation</li><li>Partner on assessment of the current state solutions and support development of roadmaps to deliver greater business value and maintain a secure and modern technology landscape.</li></ul> Required Qualifications: <ul><li> Bachelors in IT, Engineering, Computer Science, or related field. </li><li> Minimum of 10 years of relevant work experience, with at least 5+ years of experience working with financial systems. </li><li> Strong Data Analysis skills with knowledge of SAP transactions and data engineering skills in a modern IT environment. </li><li> Strong interpersonal and communication skills, with the ability to quickly establish credibility and trust with a variety of stakeholders. </li><li> Strong written and verbal communications skills including the ability to communicate with both a business and technical audience. </li><li> Critical thinker who can effectively embrace new ideas and technologies while balancing the needs of stakeholders and users. </li><li> Some experience in Web Development (HTML, CSS, API, Javascript, etc.), and Data Modeling/Design, related AWS components </li><li> D emonstrable experience in contributing to design, build, and support of large scale IT solutions using modern technologies. </li><li> Experience working on Agile teams and knowledge of Scrum framework. </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 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. 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 . 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. 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: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Required Skills: Benefits Administration, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management Preferred Skills: Business Analysis, Business Analysis, Business Case Analyses, Business Case Development, Business Data Analytics, Business Intelligence Implementation, Business Management, Business Process Development, Business Process Modeling, Business Software, Business Systems, Cash Management, Corporate Portfolio Management, Financial Process Improvement, Financial Regulation, Financial Review, Financial Technology, Inventory Management, Investment Management, Investment Performance Reporting, IT Business Management, IT Executive Management, ITIL Management, IT Performance Management, IT Project Lifecycle {+ 11 more} Job Posting End Date 05/23/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/23/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R291367

Product/Business Analyst - Intercompany Profit Elimination (Hybrid)

Job Description The Packaging Commercialization department has an exciting opportunity for a Specialist Packaging Engineer at either the Rahway, NJ or West Point, PA site. This candidate will serve as an individual contributor and foster our department mission to (1) design and develop responsible and accessible commercial packaging solutions with strong science, risk-based thinking, and focus on the customer while (2) striking the balance of being innovative and flexible to meet the evolving pipeline, while also continuously improving and standardizing our packaging solutions. Position Description: The successful candidate will have the opportunity to focus on package development for a range of traditional pharmaceuticals (oral solid dosage, oral powders, suspensions, sterile injectables, and inhaled formulations) and biopharmaceutical applications (vaccines, monoclonal antibodies, and antibody drug conjugates) as well as provide input to primary packaging for the drug component and secondary packaging of medical device and combination products. Through support of the Packaging Working Groups, the successful candidate will collaborate with peers in drug product formulation and analytical development as well as supply chain and marketing to provide technical guidance during the development of primary, secondary and tertiary packaging for new products and specialty devices. Packaging Responsibilities: <ul><li> Providing input regarding selection of primary packaging material. </li><li> Determination of package images to support commercialization as well as leading the shipping distribution strategy and coordination of shipping distribution studies efforts regarding testing robustness of packages. </li><li> The successful candidate will author packaging specifications for primary, secondary and tertiary packaging as well as provide information to support relevant sections of BLA's, NDA's, WMA's, and JNDA's. </li><li> The successful candidate will also interface with packaging component suppliers, our Company Global Packaging Technology Operations, our Company Packaging Site Operations, as well as Contract Manufacturing Operations while fulfilling their responsibilities. </li></ul> Education Minimum Requirement: <ul><li> B.S. or higher degree in Biomedical Engineering, Chemical Engineering, Materials Science, Packaging Engineering, Packaging Science, or Pharmaceutical Science with a minimum of 2 years of relevant experience </li></ul> Required Experience and Skills: <ul><li> Understanding of package development process and engineering principles </li><li> Strong scientific- and risk-based thinking </li><li> Demonstrated experience in building collaborative partnerships </li><li> Excellent verbal and written communication skills </li><li> Excellent project management skills </li><li> Ability to make rapid disciplined decisions </li></ul> Preferred Experience and Skills: <ul><li> Experience in new product pharmaceutical and/or biopharmaceutical development packaging </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: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): typical in process or finished bio-pharmaceutical materials Job Posting End Date: 05/11/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/11/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294138

Specialist, Packaging Engineer

Job Description 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. Responsibilities :<ul><li>Serves as a statistical lead in project teams.</li><li>Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.</li><li>Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other Company Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.</li><li>Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.</li></ul>The incumbent may initially work in a specific disease area. Primary activities :<ul><li>Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development</li><li>Lead a team of statistical and/or programing staff assigned to a development project as needed</li><li>Lead biostatistics in early or late clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.</li><li>Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.</li><li>Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.</li><li>May lead a team of statisticians and statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements</li><li>Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.</li><li>Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses.</li><li>Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Company Management, regulatory agencies, or individual investigators.</li><li>Represent biostatistics in regulatory interactions including presentation at advisory committee meetings</li><li>Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators. </li><li>Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.</li><li> Lead research activities for innovative statistical methods and applications in clinical trial development. </li><li> Collaborates in publication of research results in areas of applications. </li><li>Mentors and guides junior staff in functional activities.</li><li>Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical group and other committee works as needed</li></ul>Education & Skills Education and Minimum Requirement: PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master's degree with a minimum of 12 years relevant work experience. Required Skills and Experience :<ul><li>Solid knowledge of statistical analysis methodologies and experimental design.</li><li>Strong scientific leadership in design and analysis of clinical trials</li><li>Strong project management skills. </li><li>Solid knowledge of statistical and data processing software e.g. SAS and/or R. </li><li>Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V. </li><li>Excellent oral and written communication skills and strong leadership in a team environment. </li><li> Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development. </li><li>Publications in peer reviewed statistical/medical journals. </li><li>Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.</li></ul> Preferred Skills and Experience :<ul><li>An understanding of biology of disease and drug discovery and development. </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. 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: $175,440.00 - $276,200.00 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: No Travel Requirements: 10% Flexible Work Arrangements: Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date:05/13/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R271263

Senior Principal Statistician (Hybrid)

Job Description Position Description: Senior Specialist, Procurement, Global Clinical Supply The selected candidate will provide expert procurement support for the DSCS organization (Development Sciences and Clinical Supply) for clinical supply chain services (comparators, packaging, labeling, distribution, & onsite FTE's). This includes strategic sourcing of services and evaluation of suppliers, supply markets and supply chains. This role works closely with internal stakeholders in the GCS (Global Clinical Supply), GCTO (Global Clinical Trial Organization), procurement, and the finance organizations to achieve cross-functional business objectives. This role is responsible for negotiating with suppliers, contract execution, and ongoing contract management. This role will report to the Associate Director to provide high quality strategic analysis of data to drive sourcing decisions and to manage their sub-categories effectively. Primary Activities<ul><li>Sourcing - to create and execute RFIs, RFPs, RFQs together with structured information analysis and using Ariba systems.</li><li>Budget Negotiation - to conduct negotiations with suppliers based on detailed analysis of internal specifications, supplier costs, and internal benchmarks.</li><li>Contract Execution and Management - to prepare, finesse, and implement appropriate forms of contract and commitment with suppliers involving legal counsel and senior management as needed.</li><li>Stakeholder Support - to provide appropriate guidance around budgetary and contractual impacts of decisions/actions as part of a cross-functional team. Appropriately escalate issues and concerns to procurement management and other functional areas such as legal, privacy, compliance, etc.</li><li>Business Partnering - to work closely with scientific and operational stakeholders and to develop successful, long-term, strategic relationships that enable joint achievement of shared organizational objectives</li><li>Supplier Performance Management - to monitor, report, manage, and continuously improve supplier performance as part of a cross-functional team.</li><li>Supplier and Supply Market Analysis - to evaluate suppliers and supply markets based on facts, data, reports, and changes in technology with the objective of providing deep and meaningful insight to Sourcing Management teams.</li><li>Category Team Membership - to be an active member of a category team to influence the development and optimization of ongoing supplier and sourcing strategies.</li><li>Best Practice Sharing - to generate work of a world class quality that is shared and transferred to colleagues throughout procurement. </li></ul> Position Qualifications: Education Minimum Requirement: <ul><li>BS/BA preferred. Certification in six sigma desirable. </li><li>MBA or advanced degree are desirable     </li></ul>Required Experience and Skills: <ul><li>Minimum of 5 years professional experience in roles such as, but not limited to, procurement, purchasing, supply chain management, finance, vendor management, operations etc.</li><li>Analytical skills in evaluating complex budgets, comparing supplier bids and internal benchmarking data.</li><li>Ability to negotiate and influence stakeholders and suppliers in the context of a challenging clinical trial environment.</li><li>Interpersonal and communication skills. Formal presentations are required.</li><li>Must be adaptable in dealing with ambiguous and complex environments.</li><li>Able to effectively lead work within diverse cross functional teams to achieve client, department, and company goals.</li></ul>Preferred Experience and Skills:<ul><li>Knowledge and understanding of pharmaceutical industry</li><li>Experience in managing supplier interactions in roles such as, but not limited to, business development, project management, contract management, or relationship management.</li><li>Proficiency working in Excel and Ariba</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: $91,600.00 - $144,100.00 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 Job Posting End Date: 05/18/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/18/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294145

Senior Specialist, Procurement, Global Clinical Supply

Job Description We are seeking an experienced and innovative Associate Principal Scientist with a strong background in In Vitro Pharmacology to join the External Quantitative Biosciences group (ExQB). Under the broad direction of a Principal Scientist in ExQB, the candidate will support the execution of externalized In vitro projects across all discovery sites and our Research and Development Division's disease areas, as well as participate in relationship management of Contract Research Organizations (CRO). The ideal candidate will be a skilled scientist and team player with experience supporti ng collaboration s across a broad range of departments and disciplines. In collaboration with Quantitative Biosciences (QB), this individual will effectively assess and grow our Research and Development Division's external in vitro capabilities to drive pipeline support in line with our broader externalization strategies. Strong communication, leadership, problem-solving, application of soft skills , and excellent interpersonal skills are crucial to success in this role. Key responsibilities include but are not limited to the following:<ul><li>Partner with scientists from QB and other discovery functions to define and challenge resource demands, support the continued build of strategies, workflows and partner capabilities for new screening platforms and external reagent generation.</li><li>In alignment with QB externalization strategies, connect internal scientists with appropriate strategic CRO partners to support on-going needs.</li><li>Provide tactical support to successfully transfer in vitro screening funnels, assays, technology, and processes to complement internal resources in an innovative and rapidly changing environment.</li><li>Provide partner training as needed, including data QC and notebook keeping, as well as performing quarterly audits of partner notebook entries.</li><li>Participate in partner site visits to evaluate processes, capabilities, safety procedures and compliance standards as well as build workflows to compliment internal company processes.</li><li>Together with Discovery Operations, manage the scientific and operational relationship between our company and CROs by providing support for execution of governance meetings and project enablement/closeout, as well as Vendor Performance evaluation and regular onsite audits of CROs. </li><li>Support business continuity, Sourcing Management Processes, and licensing by working closely with Procurement and Business Development and Licensing teams to manage current and new providers.</li><li>Work closely with Finance and Discovery Operations to manage and forecast ongoing In Vitro sourcing spend and gather resource demand to enable Finance in generating robust profit plans. </li><li>Work closely with our company's IT organization to develop and implement IT infrastructure at partners including, but not limited to, notebook record-keeping and data QC.</li><li>Through sourcing efforts, enable a unified sourcing strategy between ExQB, External Discovery Chemistry and PDMB outsourcing groups, by implementing and growing co-localized and integrated CRO sourcing partners focusing on business continuity and improving the Design, Make, Test, Analyze cycle time.</li></ul>Required Experience and Skills: <ul><li>A Bachelor's Degree (BA/BS) in Biochemistry, Biophysics, Enzymology, Protein sciences, Cell pharmacology, molecular biology or a relevant In Vitro Pharmacology discipline with 8+ years of experience, or Master's Degree (MA/MBA/MS) with 6+ years of experience, or a PhD with 4+ years of experience in biological sciences or related discipline.</li><li>Deep understanding of In Vitro pharmacology principles and best practices across multiple disease areas with expertise in designing, interpreting, and troubleshooting studies as well as plate-based assay development and execution.</li><li>Understanding of global pharmaceutical and CRO industries with a solid understanding of drug discovery in general, as well as Quantitative Biosciences' role within the company drug discovery organization.</li></ul>Preferred Experience and Skills: <ul><li>Strong understanding of in vitro pharmacology business standards including data QC, protocol design, laboratory processes and best-practices, as well as safety standards.</li><li>A minimum of 3 years in managing CRO relationships or equivalent relationship management role.</li><li>Established network within our company, as well as Strategic CROs, and biotech / large pharma.</li><li>Successful track record of working with multiple functional groups or teams across cultural and geographic boundaries.</li></ul>The location can be at any of our company's Research Laboratories (Research and Development Division) sites including our Boston MA, Cambridge MA, Rahway NJ, West Point PA or San Francisco CA sites. 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. #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: $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: 25% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): Biological & chemical Job Posting End Date: 05/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293285

Associate Principal Scientist, In Vitro External Lead

Job Description PositionDescription: Specialist, Engineering The Specialist, Engineering, will be responsible for support of production of live virus vaccines within bulk vaccine production and/or final formulation and filling operations. This engineer will be a member of the Technical Services Deviation Management team in the Live Virus Vaccine Manufacturing End-to-End at the West Point site. The primary responsibility of the individual will be investigation initiation and closure associated with manufacturing deviations and development of actions in response to these deviations. Support will be focused on the Deviation Management process including operations support, equipment troubleshooting, implementation of process/ equipment actions, and other related duties. This position will require development of technical expertise of corresponding IPT operations. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. Responsibilities include:<ul><li>Leads and/or works as a team member on manufacturing investigations 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, engineering and process tools.</li><li>Provides technical support to manufacturing shop floor for problems and issues. </li><li>Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.</li><li>Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.</li></ul> Position Qualifications: Education Minimum Requirements:<ul><li>B.S. degree in Engineering or Sciences.</li></ul>Required Experience and Skills:<ul><li>Minimum one (1) year post-bachelor's degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with </li><li>Demonstrated ability to drive results</li><li>Strong communication, collaboration skills and ability to drive accountability</li><li>Strong problem-solving skillset</li></ul>Preferred Experience and Skills:<ul><li>Vaccine manufacturing</li><li>Sterile processing</li><li>Experience authoring investigations</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: No Travel Required Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/15/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/15/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293781

Specialist, Engineering

Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The Associate Director- IT Account Management role is responsible for providing Account Management support and IT program leadership across key initiatives in the Marketing Strategy and Commercial Operations organization for our company's Human Health US Market. In this role, you will have the opportunity to work on highly integrated teams driving critical IT programs that enable our company's marketing strategies, both digital and traditional. The challenging, fast-paced, and visible initiatives deliver significant and measurable value to our company. This role will serve as the primary point of IT accountability for all tactical program matters. We are looking for someone who is an IT Account Management/Engineering specialist with a background in the digital marketing capabilities that make up our MarTech/SalesTech stack to work with our US Market Commercial teams and to help define the evolution of our sales and marketing applications. With your expertise, you will be responsible for evolving how we use technology and data to enable the organization's committed transformation to agile ways of working and a product-oriented IT model. You'll be part of the team helping grow our service-oriented mindset as we evolve the organization into a more IT product focused operating model, with Salesforce, Veeva, and AWS as our anchor product suites. Experience with digital evolution in a large organization will be important to your success. You will help envision and launch our next generation of global solutions collaborating with colleagues and partners across the globe to meet the ambitious objectives of one of the largest and most technically progressive pharmaceutical companies in the world. The key responsibilities of the role may include but are not limited to:<ul><li> Provide Account Management oversight and leadership within the Marketing Operations domain. </li><li>Establish and maintain relationships with clients across functional areas and manage client expectations.</li><li>Define business case for, and relative priority of, proposed IT investments as well as the development of metrics, and progress realization tracking and reporting.</li><li>Collaborate with IT Value Teams to deliver both global and local tech solutions.</li><li> Influence large-scale IT initiatives through strong collaboration with business and vendor leaders. </li><li>Provide strategic expertise and thought leadership to the business clients and program delivery team.</li><li> Act as a credible change agent to align the client IT portfolio with the overall business strategy. </li><li> Manage the IT spend and strive to achieve synergies using a continuous improvement mind-set. </li><li> Act as the focal point for interactions and escalations with all other IT functions/platforms/services. </li><li> Contribute to the development of the global IT strategy and and drive its execution. </li><li> Manage IT demand and support IT portfolio planning. </li><li>Share and leverage global best practices and utilization of capabilities with the broader our Company Human Health IT community.</li><li> Travel up to 5% of the time, mostly within the Americas region and IT hubs. </li></ul>Education Minimum Requirement: <ul><li> Bachelors Degree in Information Management, Computer Science, Engineering or related field. </li></ul>Required Experience and Skills: <ul><li> Minimum 8 years relevant technical experience in Information Technology role. </li><li> Proven experience working with and deploying IT solutions. </li><li> Excellent communication and relationship skills along with high personal integrity, credibility, and energy. </li><li> Ability and inclination to influence decision making. </li><li> Results-orientation with the proven ability to develop plans and implement them. </li><li> Demonstrated enactment of robust analytical skills, effective problem solving and attention to detail. </li><li> Able to demonstrate the our Company Leadership Principles and Enterprise Leadership. </li><li> Ability to effectively partner across geographies. </li><li> Strong written and verbal communication skills in English. </li></ul>Preferred Experience and Skills:<ul><li> Prior experience working in support of pharmaceutical sales or marketing </li><li> Knowledge and experience on the force.com, Salesforce platforms a plus </li><li> Knowledge of Veeva products a plus </li><li> Knowledge of AWS technologies a plus </li><li> Digital transformation </li><li> Advanced Data and Analytics evolution experience a plus </li><li> Agile or SAFe methodology deployment </li><li> Vendor management </li><li> Master's or other advanced degree. </li><li> Fundamental technical skills (SQL, XML, etc.) </li><li> Experience with our company's systems development lifecycle (SDLC) practices .</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 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: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/23/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/23/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R292050

Associate Director, IT Account Management (Hybrid - PA)

Job Description Our Company is seeking exceptional chemists for positions within the Discovery Chemistry Department. The successful candidate will join multidisciplinary, highly collaborative discovery teams to invent novel medicines by applying innovative synthetic chemistry, analytical techniques, and data analysis to design and synthesize drug candidates and intermediates. In addition, you'll have the opportunity to expand your knowledge and skills through collaborations with talented and dedicated colleagues while advancing your career. Job responsibilities:<ul><li>Act as an expert in the laboratory, executing on program and chemistry strategy</li><li>Develop and utilize innovative synthetic, medicinal chemistry and/or chemical biology problem solving skills coupled with analysis of diverse data sets to build structure-activity relationships</li><li>Design, synthesize, purify, and characterize drug candidates and/or chemical probes in target identification and validation, hit-to-lead, and lead optimization programs</li><li>Provide scientific mentoring and technical training of team members</li><li>Establish a substantial external scientific presence including authoring significant scientific publications and presentations</li></ul>To accomplish the above, the successful candidate must be a creative and innovative scientist with strong organic synthesis, problem solving, interpersonal, collaboration and communication skills. Education:<ul><li>Bachelor's in chemistry, chemical biology, medicinal chemistry, or related scientific discipline with seven (7) years of relevant experience</li><li>Master's in chemistry, chemical biology, medicinal chemistry, or related scientific discipline with four (4) years of relevant experience</li><li>Ph.D. (received by Summer 2025) in chemistry, chemical biology, medicinal chemistry, or related scientific discipline with (0) years of experience</li></ul>Required Experience and Skills:<ul><li>Prior experience in methodology/catalysis, total synthesis, chemical biology, bioconjugate chemistry, peptide synthesis, and/or physical organic chemistry</li><li>Ability to solve complex problems</li></ul>#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: $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: Domestic/International VISA Sponsorship: Yes Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/22/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:07/08/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293391

Senior Scientist, Discovery Chemistry

Job Description The Associate Principal Programmer leads the statistical programming activities for multiple and/or large/complex late stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle. Key areas of focus include (1) the assurance of deliverable quality and process compliance, (2) effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic knowledge-base data model, (3) maintaining and managing a project plan including resource forecasting, (4) coordinating the activities of a global programming team that includes outsource provider staff, (5) membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development. Education Minimum Requirement: <ul><li>Bachelor's or Master's (preferred) Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering </li></ul>Required Experience and Skills**: <ul><li>Bachelor's degree plus minimum 9 years or Master's plus minimum 7 years SAS programming experience in a clinical trial environment</li><li>Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team</li><li>Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements. </li><li>Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.</li><li>US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.</li><li>Strong project management skills; A program leader; Determines appropriate programming methodology, assures programming consistency across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an experienced programming mentor; ability to engage key stakeholders.</li><li>Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; Understanding of statistical terminology and concepts Designs and develops complex programming algorithms;</li><li>Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders.</li><li>Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices</li><li>Experience in CDISC and ADaM standards.</li><li>Demonstrated success in the assurance of deliverable quality and process compliance.</li><li>Ability to anticipate stakeholder and regulatory requirements.</li></ul>Preferred Experience and Skills:<ul><li>Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)</li><li>Ability and interest to work across cultures and geographies.</li><li>Experience providing technical and/or programming guidance and mentoring to colleagues</li><li>Ability to complete statistical programming deliverables through the use of global outsource partner programming staff</li><li>Experience developing and managing a project plan using Microsoft Project or similar package</li><li>Active in professional societies</li><li>Experience in process improvement</li></ul>#EBRG #eligibleforERP VETJOBS SPjobs BARDS2020 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: Yes Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): NA Job Posting End Date: 05/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293682

Associate Principal Scientist Statistical Programming- Hybrid

Job Requirements Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law. The Future Talent Program features internships that lasts up to 12 weeks and will include one or more projects. These opportunities can provide you with great development and a chance to see if we are the right company for your long-term goals. Job Description: The Global Safety & Environment Intern - Occupational Safety and Health Services- will provide occupational compliance and technical support to the Wilson Teams related to occupational compliance programs (high risk work, audits, and inspections, near miss and incident investigations). Projects may include:<ul><li>Assist in High Risk Work Program in permitting, implementation, and development</li><li>Assist with GEMBAs to observe work as performed in the field versus as documented</li><li>Support investigations identifying deviations and opportunities for improvement</li><li>Perform Ergonomic evaluations and generate summary reports with sustainable recommendations</li><li>Perform Acoustical Sound evaluations and generate summary reports with sustainable recommendations</li><li>Supporting daily GEMBAs in Packaging, Warehouse, and Projects</li><li>Reviewing new / revised OSHA regulations and our Company SN updates</li><li>Revising and improving our Company Local Programs</li><li>Supporting the Safety Team</li></ul> Required Education & Experience: <ul><li>Candidates must be currently pursuing a Bachelors/ Masters Degree in Occupational Health and Safety, Engineering, or other technical degree.</li><li>Candidate must have completed at least 2 years of college course work</li><li>Candidates must be able to work full time for a period of 9-12 weeks</li><li>Candidates must have critical thinking, communication, problem solving and computer skills</li><li>Candidates must have ability to receive verbal or written direction and implement corresponding changes</li><li>Candidates must have ability to think critically about process inefficiencies and propose solutions</li><li>Candidates must have a go get it" and how can I help" mindset</li></ul> Preferred Experience & Skills : <ul><li>Candidates should have prior internship or work experience in EHS field or in the pharmaceutical industry with a focus on packaging operations</li><li>Candidates should have ability to communicate ideas and explain decisions in a clear and understandable manner.</li><li>Candidates should have ability to work in a small team</li></ul>Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security. Who we are ... We are known as Merck & Co., Inc., Kenilworth, 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 ... In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth. . FTP2022 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. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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: Intern/Co-op (Fixed Term) Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Specified Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1 Requisition ID:P-100422

Intern - Occupational Safety and Health Services, Global Safety & Environment

Job Description Position Description: Director, Business Development Responsible for leading and executing business development and commercial activities which support overall our Company's strategic and business objectives. Leads or supports internal and external Corporate, our Manufacturing Division , and HH evaluations in the areas of licensing, supply, distribution, co-marketing, acquisitions, divestitures, and restructuring business relationships. Represents our Manufacturing Division as the primary liaison / partner where our Manufacturing Division acts as supplier or customer for pharmaceutical and vaccine products and/or services. The incumbent will be responsible for leading and managing cross functional teams to conduct due diligence assessments. The incumbent will conduct formal report-outs to our Research & Development Division , Human Health, and our Manufacturing Division Senior Leaders.<ul><li>Executes business development and commercial activities in the evaluation and implementation of licensing, acquisition, supply, distribution, co-marketing, divestiture, and re-structuring business relationships. Collaborates closely with our Research & Development Division , and Corporate Business Development functions, Legal, our Manufacturing Division functional areas (e.g. Finance, External Manufacturing, Supply Chain Management, Quality, Technology, Analytical, Commercialization and Operations), as well as o ur Research & Development Division Process, Analytical and CMC Regulatory groups.</li><li>Defines, assesses, and presents business analyses for potential transactions requiring manufacturing input. </li><li>Serves as the central point of contact between our Manufacturing Division and all internal Company business areas to ensure appropriate manufacturing input is effectively incorporated into the potential transaction identifying risks, mitigation strategies, and value drivers. </li><li>Additionally, brings visibility and preparedness to post contract execution commitments so that our Manufacturing Division can be prepared to fulfill new responsibilities as a result of the transaction. </li><li>Leadership in negotiating supply and technical contracts that impact our Manufacturing Division in addition to being a core team member to any transaction team that has a manufacturing/supply component. </li><li>Analysis includes resource requirements, supply, inventory, demand management, product costs, intellectual property, quality, capital needs, environmental, safety and industrial hygiene, inventory and production plan, compliance and financial reviews.</li><li>Ensures and facilitates the transition of assigned licensing arrangements to the appropriate our Research & Development Division and/or our Manufacturing Division functional support areas. </li><li>Facilitates the creation of our Research & Development Division or our Manufacturing Division external alliance relationships for new partners. </li><li>Drives strong business relationships to ensure effective communications during implementation of the partnership.</li><li>Completes other project activities as assigned and executes activities with minimal supervision. </li><li>Complies with all organization policies, procedures, and guidelines in execution of job functions.</li><li>Supports the LATAM Regional Business Development activities and coordinates the creation and review of business cases that enable sale of our Company's Commercial Products and related Tech Transfers.</li><li>Works closely with the LATAM Corporate BD Team, HH Commercial Leads and our Manufacturing Division Value Chain Management, GSEC (Global Science, Engineering & Commercialization) and Quality groups.</li></ul> Position Qualifications: Education Minimum Requirement: <ul><li>Required: Bachelor's degree</li><li>Preferred: Graduate degree is desirable in Business, Supply Chain Management, Science, or Engineering related disciplines</li></ul>Required Experience and Skills: <ul><li>Minimum 12+ years of experience with increasing responsibility in Manufacturing Operations, Supply Chain Management, Quality, Technology, Global Procurement, Lean - Six Sigma and/or related business areas. </li><li>Candidate must have knowledge of our Manufacturing Division organization and possess excellent leadership, collaboration, and communication skills. </li><li>Proven experience in negotiating contracts with third parties is essential. Experience in negotiating manufacturing and supply terms is strongly desired.</li><li>Proven experience leading cross functional teams is essential.</li><li>Previous third-party commercial experience is strongly desired. </li><li>Candidate must be accomplishment oriented (self-motivated and persistent), possess a "business owner" mentality, possess the ability to influence without authority, and demonstrate the ability to effectively operate in an ambiguous/changing environment </li><li>The position requires sound understanding of our Manufacturing Division divisional strategy and objectives, key company business processes, and general understanding of financial and manufacturing process / issues. </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: $164,800.00 - $259,400.00 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 Job Posting End Date: 05/22/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/22/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294312

Director,  Business Development

Job Requirements This posting has been created to pipeline talent for prospective roles that we anticipate will be needed in the future for our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement. Expand your skills and experience in audit through a career path in the pharmaceutical industry. Become part of a dynamic team that offers a flexible work environment, leadership development programs, travel opportunities and workplace inclusion. We are a leading pharmaceutical company committed to improving health through innovative research, development and production of medicines. With a strong emphasis on ethical practices, employee wellness and fostering an inclusive culture, we strive to make a positive impact on patients' lives. Under the direction of the Client Audit Director (CAD) and the Auditor-in-Charge (AIC), the Senior Specialist will:<ul><li>Participate in the execution of financial, operational, SOX 404 and IT audits, integrated audits and process audits, both domestic and abroad to maintain a strong internal control environment at our company.</li><li>On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management supervision in addition to actively performing audit work.</li><li>Under the direction of the AIC, partner with colleagues and clients, support groups, and other organizations to effectively complete all assigned audit work.</li><li>Execute audit programs and work papers (including walkthroughs and sample testing) in line with the established quality standards and timelines.</li><li>Collaborate with the audit team in the writing of audit summaries of issues and reports which accurately describe identified control concerns, associated risks, and appropriate recommendations.</li><li>Participate in department projects and ensure the realization of the specified results.</li><li>Maintain the highest standards of professionalism and independence in the execution of duties with the highest level of integrity and quality. Show good judgment in the conduct of work.</li></ul>Work Experience Education Minimum Requirement:<ul><li>Bachelor's degree in accounting/finance.</li><li>Certified Public Accountant (CPA) or all 4 parts passed.</li></ul>Required Experience and Skills:<ul><li>A minimum of 3 years work experience in internal audit, public accounting, or general accounting.</li><li>Experience with audit methodology and internal controls.</li><li>Excellent interpersonal skills, including the ability to interact effectively with client and business process owners as well as Merck Corporate Audit and Assurance Services (MCAAS) colleagues.</li><li>Effective oral and written communication skills.</li><li>Understanding of information technology and ability to use various applications and systems.</li><li>Strong time management skills and the ability to work within a team as well as independently.</li><li>Attention to detail and the ability to multi-task are essential to the position.</li><li>Ability to travel both domestically and internationally up to 30% of the time. </li></ul>Requisition ID:P-100819

Senior Specialist, Audit - Rahway, NJ, United States

Job Description Position Description: Senior Specialist, Procurement, Analytical Labs The selected candidate will provide expert procurement support for the Development Sciences and Clinical Supply (DSCS) organization for third party analytical laboratories. This includes strategic sourcing of services and evaluation of suppliers, supply markets and supply chains. This role works closely with internal stakeholders in the Analytical R&D in our Research & Development Division , Enterprise Quality supporting our Manufacturing Division , testing, procurement, and the finance organizations to achieve cross-functional business objectives. This role is responsible for negotiating with suppliers, contract execution, and ongoing contract management. This role will report to the Associate Director to provide high quality strategic analysis of data to drive sourcing decisions and to manage their sub-categories effectively. Primary Activities<ul><li>Sourcing - to create and execute RFIs, RFPs, RFQs together with structured information analysis and using Ariba systems.</li><li>Budget Negotiation - to conduct negotiations with suppliers based on detailed analysis of internal specifications, supplier costs, and internal benchmarks.</li><li>Contract Execution and Management - to prepare, finesse, and implement appropriate forms of contract and commitment with suppliers involving legal counsel and senior management as needed.</li><li>Stakeholder Support - to provide appropriate guidance around budgetary and contractual impacts of decisions/actions as part of a cross-functional team. Appropriately escalate issues and concerns to procurement management and other functional areas such as legal, privacy, compliance, etc.</li><li>Business Partnering - to work closely with scientific and operational stakeholders and to develop successful, long-term, strategic relationships that enable joint achievement of shared organizational objectives</li><li>Supplier Performance Management - to monitor, report, manage, and continuously improve supplier performance as part of a cross-functional team.</li><li>Supplier and Supply Market Analysis - to evaluate suppliers and supply markets based on facts, data, reports, and changes in technology with the objective of providing deep and meaningful insight to Sourcing Management teams.</li><li>Category Team Membership - to be an active member of a category team to influence the development and optimization of ongoing supplier and sourcing strategies.</li><li>Best Practice Sharing - to generate work of a world class quality that is shared and transferred to colleagues throughout procurement. </li></ul> Position Qualification: Education Minimum Requirement: <ul><li>BS/BA preferred. Certification in six sigma desirable. </li><li>MBA or advanced degree are desirable     </li></ul>Required Experience and Skills: <ul><li>Minimum of 5 years professional experience in roles such as, but not limited to, procurement, purchasing, supply chain management, finance, vendor management, operations etc</li><li>Analytical skills in evaluating complex budgets, comparing supplier bids and internal benchmarking data.</li><li>Ability to negotiate and influence stakeholders and suppliers in the context of a challenging clinical trial environment.</li><li>Interpersonal and communication skills. Formal presentations are required.</li><li>Must be adaptable in dealing with ambiguous and complex environments.</li><li>Able to effectively lead work within diverse cross functional teams to achieve client, department, and company goals.</li></ul>Preferred Experience and Skills:<ul><li>Knowledge and understanding of pharmaceutical industry</li><li>Experience in managing supplier interactions in roles such as, but not limited to, business development, project management, contract management, or relationship management.</li><li>Proficiency working in Excel and Ariba</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: $91,600.00 - $144,100.00 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 Job Posting End Date: 05/18/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/18/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294148

Senior Specialist, Procurement, Analytical Labs

Job Description This role is a Senior Specialist who would focus on Drug Substance Localization as well as Drug Product Localization. The function of this position is to provide engineering technical support for the manufacture of Drug Substance and Drug Product at external partners as well as at the company's West Point, PA location. The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area such as localization or span across multiple areas of focus based on the West Point Technical Operations business needs and priorities. The selected candidate will be responsible for:<ul><li>Serving as the main point of contact and SME for a product franchise support of drug substance (Fermentation and Purification) and/or drug product at external partners. May require support of additional products or family of products. The support can include but is not limited to tech transfer, validation, change controls, regulatory submissions, deviations and training of employees from external partners.</li><li>Responsible for responding to questions from external partners.</li><li>Collaborate effectively with the external partners and the company's External Manufacturing.</li><li>With in depth product expertise, complete deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.</li><li>Authoring technical protocols, executing studies and reporting results/conclusions in support of product tech transfers, process improvement projects and deviation investigations. The individual will be required to utilize sound engineering principles to support qualified validation processes as required per current Good Manufacturing Practices (cGMPs).</li><li>Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in equipment, automation or process troubleshooting or to provide immediate responses to deviations and/or protocol exceptions.</li><li>Supporting team safety, environmental, and compliance objectives.</li><li>Collaborating effectively with the area Managers, Operators/Mechanics, support groups (Mechanical Services, Automation, Technical Operations), Quality, and Planning.</li></ul>Other responsibilities that the candidate will get involved in as required:<ul><li>Supporting product Annual Review expectations including Continued Process Verification Reports, including pulling data, generating charts and statistically analyzing the data to identify whether preventative actions are required.</li><li>Approving new or updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures).</li><li>Performing validation assessments for proposed changes impacting the qualified processes.</li><li>Managing investigation, project and validation study timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.</li><li>Actively using and championing the use of Lean Six Sigma (LSS) tools, both problem solving and day-to-day operational activities</li><li>Leading cross functional teams and acting as an individual contributor to drive change control and improvement projects across compliance, and strategic, including projects aimed at improving Right-First-Time performance, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times. </li><li>Authoring and approving Change Control documentation for complex process, validation, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines. </li><li>Preparing source documentation for regulatory filings, supporting and serving as a lead SME during regulatory inspections related to process overviews, investigations, projects and validation.</li></ul>Education Minimum Requirement: <ul><li>B.S. or equivalent in Science Related Field</li></ul>Required Experience and Skills: <ul><li>Engineering or Science educational background</li><li>Minimum of 5-years of post BS degree experience in vaccines in support of Production, Process Engineering, Technical Operations or related experience</li><li>Hands-on experience in supporting fermentation or purification of vaccines</li><li>Hands-on experience in supporting formulation and aseptic filling including manufacturing scale filling isolators, RABS, or closed system processing</li><li>Product franchise Tech Services experience</li><li>Support of deviation investigations</li><li>Support project work</li><li>Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills</li></ul>Preferred Experience and Skills:<ul><li>Experience with Trackwise, MEDS, SAP, MII, Delta V</li><li>Experience with change control documentation and execution</li><li>Participation in internal audits, regulatory inspections and/or interactions with regulatory agencies.</li><li>Experience with Clean-in-Place and Sterilize-in-Place systems</li><li>Ability to read Piping and Instrumentation Diagrams is desired</li><li>LSS experience</li><li>Experience with Tech services support activities for introduction or launch of new product</li></ul>Travel requirement of 25% 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". 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: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/20/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/20/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R292464

Senior Specialist, Engineering

Job Description Job Summary: This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a global, cross-functional team. Job Responsibilities: Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include:<ul><li>Serving as the lead clinical scientist on a clinical trial team.</li><li>Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.</li></ul> Other responsibilities include: <ul><li>Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents/amendments); Partners with the Study Manager on study deliverables.</li><li>Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.</li><li>Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.</li><li>Providing tactical/scientific mentorship to other clinical scientists.</li></ul> Core Skills: <ul><li>Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)</li><li>Ability to manage multiple competing priorities with good planning, time management and prioritization skills</li><li>Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions</li><li>Interact with key stakeholders across department, division, and company. Role requires a proactive approach, strategic thinking and leadership in driving toward study goals.</li><li>Influence opinions and decisions on internal and external customers/vendors, across functional areas, and within the division</li><li>Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment.</li><li>Problem solving, prioritization, conflict resolution, and critical thinking skills</li><li>Build team capabilities through proactive coaching</li><li>Strong communication, technical writing, and presentation skills</li></ul> Education/Experience: <ul><li>Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +3 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree</li><li>Degree in life sciences, preferred.</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. MRLGCTO #eligibleforERP CSSMHiring CSSMOncology 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: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/12/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/12/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293932

Senior Clinical Scientist, Oncology

Job Description Our company's Research Laboratories in South San Francisco is seeking a highly motivated and versatile Scientist with a strong background in sample management and analytical science to join our Quantitative Biosciences (Pharmacology) department. The successful candidate will be accountable for maintaining the department compound inventory, implementing a robust compound management workflow using lab automation, fulfilling compound requests, and performing quality control to maintain accuracy and integrity. In addition, this individual will also contribute to discovery research by supporting bioanalytical method development and execution for internal projects, in collaboration with a team of multidisciplinary quantitative scientists. We value transparent communication, critical-thinking, teamwork, and rigorous scientific exploration. If you are a highly motivated individual and team player with a strong desire to impact drug discovery, we invite you to consider joining our team. Key job duties:<ul><li>Implement and support a compound management system using lab automation (Beckman Access) and commercial inventory and integration software (Mosaic, TFM, etc.)</li><li>Receive and process liquid compound samples from internal sources to be added to the inventory, including proper labelling, sorting, and storage</li><li>Manage and process compound requests to support drug discovery, including sorting and plating liquid samples for in vitro assays and preparing samples for storage and shipment</li><li>Accountable for meeting timelines for all compound requests and collaborating with other scientists and stakeholders to fulfill various compound request requirements</li><li>Work with automation engineer to optimize/improve workflow and productivity</li><li>Support bioanalytical method development and execution (HPLC, LC/MS, GC/MS, etc.) for research projects, in collaboration with other scientists</li><li>Ensure all sample management and analytical equipment and systems are properly maintained, serviced, and in good working condition</li></ul>Education:<ul><li>Bachelor's or Master's in Analytical Chemistry, Chemical Engineering or other related scientific discipline</li></ul>Required Experience and Skills:<ul><li>Must have three (3) years of relevant experience in a biotech or pharmaceutical setting</li><li>Strong knowledge of compound management processes, with an excellent understanding of inventory management, quality control and logistics</li><li>Proven expertise in compound registration and sample management informatics platforms (Mosaic, Dotmatics, Benchling, etc.)</li><li>Demonstrated proficiency with compound sample preparation using various liquid handlers and dispensers (Echo, Bravo, Biomek, Certus, Multidrop, etc.)</li><li>Hands-on experience with analytical instrumentation, method development and execution (HPLC, LC/MS, GC/MS, etc.)</li><li>Good multi-tasking, record keeping, organization, and communication skills with demonstrated ability to work effectively in an interdisciplinary and team-oriented environment</li></ul>Preferred Experience and Skills:<ul><li>Hand-on experience with Beckman Access robotic system and Hamilton Verso automated sample store</li><li>Hand-on experience with biological sample processing, extraction, and bioanalytical assays</li></ul>#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: $99,400.00 - $156,500.00 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: No Travel Required Flexible Work Arrangements: Shift: 1st - Day Valid Driving License: No Hazardous Material(s): yes Job Posting End Date:05/31/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R273436

Scientist,  Sample Management and Analytical Science

Job Description The Senior Medical Writer is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer:<ul><li>Demonstrates independence in preparing clinical regulatory documents (e.g., protocols, clinical study reports, investigator's brochures, clinical sections of submissions) per company and regulatory requirements.</li><li>Applies an in-depth knowledge of medical writing responsibilities, including document planning and authoring, and interpretation of data.</li><li>Is a scientific contributor and works collaboratively on document-specific cross-functional teams while demonstrating an understanding of team and project leadership responsibilities.</li><li>Applies knowledge of clinical development, relevant regulations, disease areas, and company products.</li><li>Applies critical thinking, problem solving and negotiation skills to identify innovative solutions to challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics.</li><li>Applies knowledge of medical writing-specific tools and technology platforms.</li><li>Participates in or leads initiatives to improve medical writing processes and standards.</li><li>May participate in orientation and coaching of junior team members or contract writers.</li></ul> Minimum Education Requirement and Skills: <ul><li>Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine).</li><li>Bachelor's degree with 5+ years, master's degree with 4+ years, or doctorate degree with 3+ years of relevant medical writing experience in the pharmaceutical and/or biotech industry.</li><li>Ability to prepare, with minimal supervision, a subset of clinical regulatory documents (e.g., clinical study reports, investigator's brochures, clinical sections of submissions) per regulatory requirements and industry guidelines.</li><li>Ability to present clinical data clearly and objectively, with minimal supervision.</li><li>Demonstrated critical thinking and problem-solving capabilities.</li><li>Ability to manage multiple projects in a deadline-driven environment, work collaboratively, and lead authoring teams of medical writers and cross-functional members.</li><li>Excellent oral and written communication and presentation skills.</li><li>Technical expertise in office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint); familiarity with concepts of structured content management preferred.</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. MRLGCTO MW20 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: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/18/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/18/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294173

Senior Medical Writer - Oncology

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 dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. We are seeking a Growth and Improvement minded Manufacturing Quality Assurance Specialist | Integrated Production Team that can help drive our Strategic Operating Priorities.<ul><li>Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs</li><li>Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)</li><li>Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape</li><li>Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world</li><li>Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us</li></ul>Summary, Focus and Purpose The Manufacturing Quality Assurance Specialist | Integrated Production Team provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model and with guidance from the IPT Quality Lead, ensures product quality process quality to facilitate the release of product to the marketplace and ensures proper control of material through maintenance of the SAP system. You will provide Generalist Quality support directly to the production floor, to include oversight for adherence to cGMPs, right-first-time completion of production GMP documentation, effective investigation of deviations and support for change controls and will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance. Job functions are completed primarily on the production shop floor and in a team environment. Key Functions<ul><li>Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion</li><li>Completes batch release of supported products, this includes release to Markets outside of the USA</li><li>Collaborates with Planning, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates</li><li>Assists in sending samples/lab reagents to release authorities</li><li>Completes required SAP transactions to release product in SAP</li><li>Ensures proper identification of release status and control of materials through maintenance of quarantines in SAP and through physical tagging of material</li><li>Completes, reviews and sends release protocols to regulatory agencies</li><li>Supports Regulatory inspections | Assists in identifying and preparing documentation for review during a regulatory inspection. Serves as a subject matter expert and presents documentation to regulatory inspectors</li><li>Provides coaching and mentoring of manufacturing supervisors and operators</li><li>Conducts Quality review / approval of new and updated SOPs and CJAs</li><li>Assists with training of incoming personnel and ensures compliance with departmental procedures</li><li>Actively participates in the Tier process and uses this forum to escalate concerns and best practices</li><li>Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans</li></ul>Note: This position is on first shift. Education | Experience | Skills | Knowledge<ul><li> Required Education : Bachelor's degree*. Degree in life science, science discipline, or engineering field (preferred); candidates with degrees in other field; candidates with degrees in other fieldswill be considered if accompanied by significant relevant experience.</li><li>* In lieu of Bachelor's degree as described above, equivalent direct experience of minimum 1-2 years of work experience in GMP Manufacturing or Laboratory environment,Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, orrelated industry experience in a laboratory, manufacturing, science related or regulated setting.</li><li> Required Experience :Minimum 1 year of relevant post-degree work experience in GMP Manufacturing or Laboratory environment,Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, orrelated industry experience in a laboratory, manufacturing, science related or regulated setting.</li></ul>Preferred Experience and Skills:<ul><li>Familiarity with vaccine and/or pharmaceutical processing.</li><li>Familiarity with release of product, deviation management and change control is a key skill necessary for success in this position; prior experience in these areas is a strong plus.</li><li>Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is a strong plus.</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. 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 MSJR 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: No Travel Required Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/13/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/13/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293893

Specialist, Quality (Barrier IPT)

Job Description TheVaccine Customer Representative (VCR) supports customers by providing clinical information on our Company's vaccines, as well as education and resources . They do this to support customer operational and financial needs such as reimbursement information and contract adherence in an effort to help the provider or system increase their immunization rates among appropriate patients and help protect them from vaccine preventable diseases . The Vaccine Customer Representative (VCR) i s the primary point of contact for a variety of customers within their assigned geography. These customers may include health care pro viders such as physicians, nurses, pharmacists as well as quality directors, immunization managers, and office managers. W ithin their geography there are a diverse set of health care locations that they will call upon in order to execute their role including : clinics , health departments, integrated delivery systems , and hospitals . The VCR is a key member of the local Customer Team that works collaboratively with other field-based employees such as the Vaccine Key Customer Leader (VKCL), Vaccine Medical Affairs Leader (VMAL), Region Medical Director (RMD) as well as other members of the extended team . Territory Information: <ul><li> This territorycovers: Jackson, TN and customers within a 75-mile radius. </li></ul><ul><li> The ideal location to reside is within this territory. </li></ul><ul><li> Travel (%) varies based on candidate's location within the geography. </li></ul> The primary activities include: <ul><li> Engaging in balanced product sales presentations with Health Care Providers and Health Care Business Professionals to align customer needs and our Company's vaccine attributes in accordanc e with product labeling , and CDC and professional society recommendations. </li><li> Provid ing Company Vaccine management with updates on customer needs as it relates to helping them improve patient health outcomes , customer feedback, marketplace dynamics, and progress towards quality goals. </li><li> Provid ing customers with key insights by k eeping apprised of professional and health care environment knowledge through self-study of company - provided scientific , product and marketplace information, attendance at product workshops and conferences, as well as consistent and ongoing review of our Company's promotional materials . </li><li> Utilizing analytical skills and tools to e ngage customers in quarterly business reviews regarding their vaccine contract to educate customers on the best ways to maximize their contract performance across the Company portfolio . </li><li> Assist ing customers with education to improve their organization's immunization rates through adherence to quality-based programs using appropriate tools such as Vaccine IQ . </li><li> Regularly monitor ing their business performance against objectives using company provided tools. </li><li> Develop ing a territory level business plan that focuses on improving immunization rates with assigned customers in accordance with Our Company's policies, standards, and ethics. </li><li> Maintain ing product knowledge and certification on the entire Company vaccine portfolio along with knowledge of the CDC immunization schedule for both pediatric and adult vaccines. </li></ul> Specifically: <ul><li> Within select customer accounts , act s as primary point of contact for the customer, meet with key customers/personnel to maintain understanding of their current practice structure, business model, and key influencers ( Managed Care Organization /payers , employers, state policy ) , and their patients' needs . Identifies business opportunities and makes information available to relevant stakeholders to support th e identified immunization needs. </li><li> For select customer accounts, coordinate with our Company's customer team (Account Executives, Integrated Delivery System team, Solutions support teams , etc.) to outline customer strategy for interactions/ relationships aimed at improving immunization rates . </li></ul> Position Qualifications: Education: <ul><li> Bachelor's Degree with 0-3 years Sales experience OR a minimum of high school diploma with at least 4 years of relevant work experience which could include: professional sales, experience in marketing, military, or healthcare/scientific field (pharmaceutical, biotech, or medical devices). </li></ul> Required Skills: <ul><li> Demonstrated aptitude to excel in current or previous educational or professional roles </li><li> Ability to work both independently and within a team environment </li><li> Strong organizational and time management skills </li><li> Excellent interpersonal and communication skills </li></ul> Other Requirements: <ul><li> Valid Driver's license </li></ul> Preferred Skills/Experience: <ul><li> Ability to convey technical concepts accurately and clearly </li><li> Prior experience working in a technical/scientific field or healthcare environment </li><li> Previous sales, account management, consultative, or customer service experience </li><li> Experience developingand executing a plan for engaging customers and meeting customer needs </li><li> Understanding of Marketing/Sales &/or Marketing/Sales Support Functions/Operations </li><li> Ability to analyze metrics to assess progress against objectives </li><li> Vaccine's experience </li></ul> MSJR 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". 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: Yes Hazardous Material(s): n/a Job Posting End Date: 05/22/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/22/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R292267

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