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About the Role Over 108,000. That's how many US patients our oncology products touched in 2018. Novartis is deeply committed to transforming the lives of people living with solid tumors, blood cancers and serious or life-threatening blood disorders. We believe that anyone living with these conditions has the right to a life free from pain, free from symptoms and free from disease - this is our vision for the future. As the Clinical Development Medical Director (CDMD) in RLT, you will lead the planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective and drive execution of the plan, enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs. In Clinical Development Oncology, our aim is to design innovative, patient friendly clinical development plans to rapidly bring outstanding treatments to patients, caregivers and healthcare systems. We are striving to develop treatments for Lung, Breast & Prostate Cancers, MDS & AML, CML and sickle-cell disease, and are pushing the boundaries of innovation with CAR-T and Radioligand therapies. Your key responsibilities: &bull; Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program &bull; Lead development of clinical sections of trial and program level regulatory documents &bull; Drive execution of the program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates &bull; Support the Global Program Clinical Head in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety colleagues &bull; Support the Clinical Development Head by providing medical input into the Clinical Development Plan, Integrated Development Plan and Clinical Trial Protocol reviews. and contributing to development of disease clinical standards for new disease areas &bull; As a medical specialist, supporting the GPCH or CDH in interactions with external and internal partners and decision boards &bull; May work with the Novartis Institute of Biomedical Research/ Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences together with other medical matters, as needed. This position will require 1% travel as defined by the business (domestic and/ or international). The ideal location for this role is East Hanover, NJ, but remote work may be possible (there may be restrictions based on legal entity). Please note that this role would not provide relocation as a result. If the associate is remote, all home office expenses and travel/lodging to the East Hanover or corporate site for periodic live meetings will be at the employee's expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements What you'll bring to the role: &bull; MD or equivalent medical degree is required, in addition to extensive knowledge and clinical training in medical/scientific areas, RLT. &bull; 3+ years minimum in clinical research or drug development. &bull; Working knowledge of Hematology/Oncology with a proven track record to interpret, discuss and present efficacy & safety data relating to clinical trials. &bull; Solid understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes. &bull; Demonstrated ability to establish effective scientific partnerships with key partners. Desirable: &bull; Clinical practice experience 4+years (including residency) preferred. &bull; Previous global people management experience is preferred, though this may include management in a matrix environment. You'll receive: Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme and learning and development opportunities as well. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis? 769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $257,600 - $386,400/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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Clinical Development Medical Director

About the Role Internal Job Title: Discovery Postdoctoral Fellow Position Location: Cambridge, MA, onsite About the role: Come join Novartis Biomedical Research as a Discovery Postdoctoral Fellow and contribute to tackling one of the most pressing challenges in the modern society: Neurodegenerative diseases. In this role you will blend multi-modal genomic, transcriptomic, high-content imaging and computational biology to both screen for and profile therapeutic targets with molecular and cellular resolution. Your goal is to develop a novel technology to advance the study of neurodegenerative disease and identify novel regulators of disease. You will be part of our interdisciplinary unit, Neuroscience Targets and Technology. Robert Ihry and Young Don Kwak will serve as your mentors in Cambridge, MA. Discovery Fellows have a unique opportunity to conduct innovative, interdisciplinary research and are expected to publish their results in the high-profile scientific journals. We collaborate across scientific and organizational boundaries, with a focus on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. You will join our postdoctoral community for dedicated events, including the monthly postdoctoral seminars and our annual Research Day Symposium. All Fellows participate to our robust curriculum designed to develop scientific and professional skills. The postdoctoral term is up to 4 years. As a Discovery Fellow, your key responsibilities will include: &bull; Working independently as well as with interdisciplinary teams &bull; Engaging the organization with your energy and enlist the support of our research teams &bull; Designing your project, modifying accordingly, and making the most or your precious time &bull; Implementing novel multi-modal technologies for investigating novel biomarkers, identifying and validating new targets, and gaining new insights into the underlying mechanisms of neurodegenerative diseases. &bull; Establishing yourself as an innovator through impactful publications Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements What You'll Bring to the Role: &bull; PhD or MD/PhD in neuroscience, genomics, cell biology or related field (PhD students in the last year of their thesis work, are eligible to apply). &bull; A strong independent thinker with a focus on discovery and problem-solving, and a passion for fundamental exploratory research and boundless curiosity. &bull; Hands-on experience in functional genomics (Perturb-seq or pooled CRISPR screening, capsid library evolution), genomics (eg.,10x single cell genomics, ChIP-seq, bulk RNA-seq), spatial transcriptomics, high content screening. Data science would be advantageous, but not mandatory. &bull; Strong publication record or other scientific achievements (i.e. awards, patents, grants). &bull; Excellent analytical, communication, presentation, and organizational skills for conducting research of the highest quality and a keen learner's attitude. How to apply: Please submit your CV and cover letter by April 1 for consideration. Please make sure to discuss in the cover letter how this training program will help you fulfill your career goals. #pdx #LI The pay rate for this position at commencement of employment is expected to be $75,000 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Discovery Postdoctoral Fellow, Neuroscience Multi-Modal Genomics

About the Role This is a remote position To write, review and/or handle the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative documentation-related consultancy to other line functions. To coach/mentor and/or train less experienced writers. Major Activities 1. To author, review and/or independently handle high quality clinical and safety documents: Clinical Study Reports (CSR), Risk Management Plans (RMP), CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities (e.g., Briefing Books, answers to questions). 2. Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing specialist content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines. 3. Ad-hoc member of Clinical Trial Team (CTT) / extended member of Safety Management Team (SMT). Core member of multiple Clinical Submission Teams (CST). Extended member of Global Clinical Teams (GCT). 4. Input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions. 5. Documentation specialist in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines. Provide content and strategic expertise for clinical portions of the CTD. 6. Program Writer for large and/or complex programs ensuring adequate medical writing resources are available for assigned program and consistency between documents. 7. Lead process improvement in RWS and cross-functional initiatives and/or activities. &bull; Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable. &bull; ≥ 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical writing processes. preferred &bull; Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). &bull; Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs. &bull; Excellent communication skills (written, verbal, presentations) &bull; Expert knowledge of biostatistics principles. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements &bull; Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable. &bull; ≥ 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical writing processes. preferred &bull; Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). &bull; Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs. &bull; Excellent communication skills (written, verbal, presentations) &bull; Expert knowledge of biostatistics principles. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $144,000-$216,000year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Associate Director Regulatory Writing

About the Role This is a Remote Position 1.To author, review and manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP), submission documents (e.g., summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics). 2.Core member of Clinical Trial Team (CTT) / contributor to Safety Management Team. 3.Major contributor to planning of data analyses and presentation used in CSRs and submission documents. 4.Documentation specialist in CTTs and Clinical Submission Teams (CST) to ensure compliance of documentation to internal company standards and external regulatory guidelines. Provide content expertise and guidance for clinical portions of the CTD. 5.Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents. Extended member of International Clinical Team (ICT) 6.Lead Writer for simple submissions, contributing to key messaging and pooling strategy, providing content guidance, and ensuring compliance of documentation to internal company standards and external regulatory guidelines. Core member of CST. 7.Contribute to process improvement in RWS and/or cross-functional initiatives or activities. 8.Coach and/or mentor less experienced writers. The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600 year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements &bull; ≥ 4 years medical writing experience or other relevantpharma industry experience combined with scientific andregulatory knowledge, plus in-depth knowledge of medicalwriting processes. Preferred &bull; Advanced knowledge of and experience in global regulatoryenvironment and process (key regulatory bodies, keydocuments, approval processes, safety reportingrequirements). Preferred &bull; Advanced knowledge of and repeat experience in globalregistration of drugs (complex submissions). &bull; Excellent communication skills (written, verbal, presentations) &bull; Advanced knowledge of biostatistics principles. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Senior Regulatory Writer

Summary This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10% travel. The Director, Customer Engagement Launch Acceleration will bring an enterprise approach and perspective to advise strategic decisions around product launches. This role will work with key partners across the organization to understand launch needs and provide launch implementation and acceleration recommendations to the VP, Customer Engagement Strategy & Launch Acceleration. You will need therapeutic area knowledge within Oncology and launch expertise to support the synthesis of known standard processes, brand strategy, and competitive research to provide significant recommendations that resolve plans of action for the Customer Engagement team. #LI-Remote About the Role Key Responsibilities: <ul><li> Capture key insights and findings across therapeutic areas, internal roadmaps, customer insights, and the external driven environment to develop and evolve launch standard processes, advise, and inform strategic decisions to support future launches for the organization. </li><li> Cultivate, establish relationships, and partner with matrix partners, such as product, data and analytics, finance, legal, compliance, marketing leadership and others to support efficient field deployment which includes tools, technologies, tactics which will increase efficiency. </li><li> Partner with internal key partners to ensure the real-world voice of the customer is embedded into strategic planning to support innovation, business planning and field priorities. </li><li> Assist in the design and evolution of strategies accordingly to improve Launch Acceleration across Customer Engagement and the enterprise. </li><li> Ensure launch and operational excellence for priority brands and build standards that can be applied at an enterprise level for Customer Engagement. </li><li> Bring a novel lens to enterprise-level performance KPIs to gain new insights around the launch process and early market uptake, while partnering with analytics for metrics. </li><li> Support Sales Leadership to address issues and capitalize on opportunities specific to a product or therapeutic area in the launch period. </li><li> Deliver tailored solutions to individual launch scenarios while maintaining optimization through standard processes. </li><li> Ensures alignment to, compliance with, and ownership of all NPC policies, including the Code of Conduct and all applicable laws and regulations. </li></ul>Essential Requirements: <ul><li>Bachelor's degree in business, or related discipline. MBA preferred.</li><li>8+ years' experience in pharmaceutical, biotech, healthcare, or healthcare consulting industry, inclusive of at least 2+ different types of cross-functional roles/experience.</li><li>4+ years' experience in of experience on product launches in the Life Sciences Industry with 1+ years' experience in forecasting, product launch analytics, and/or BD&L.</li><li>2+ years' experience working in the oncology space for any healthcare company - must have deep understanding of this space and its dynamics.</li><li>Proven experience analyzing sophisticated situation and processes and effectively integrating and synthesizing the data to form a complete cohesive picture and actionable insights.</li><li>Experience in project management and translation of strategy into execution.</li></ul>Desirable Requirements: <ul><li>2+ years within a Healthcare Consulting Group.</li><li>Experience working in healthcare start-ups, with sales or sales operations experience.</li></ul>Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $192,000 and $288,000/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Company will not sponsor visas for this position. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. <ul></ul>Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Director, Oncology Customer Engagement Launch Acceleration - Remote

Summary This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10% travel. The Director, Customer Engagement Launch Acceleration will bring an enterprise approach and perspective to advise strategic decisions around product launches. This role will work with key partners across the organization to understand launch needs and provide launch implementation and acceleration recommendations to the VP, Customer Engagement Strategy & Launch Acceleration. You will need therapeutic area knowledge of at least one of Novartis key focus areas (Neuroscience, Immunology, or Cardiovascular-Renal-Metabolic), and launch expertise to support the synthesis of known standard processes, brand strategy, and competitive research to provide significant recommendations that resolve plans of action for the Customer Engagement team. #LI-Remote About the Role Key Responsibilities: <ul><li> Capture key insights and findings across therapeutic areas, internal roadmaps, customer insights, and the external driven environment to develop and evolve launch standard processes, advise, and inform strategic decisions to support future launches for the organization. </li><li> Cultivate, establish relationships, and partner with matrix partners, such as product, data and analytics, finance, legal, compliance, marketing leadership and others to support efficient field deployment which includes tools, technologies, tactics which will increase efficiency. </li><li> Partner with internal key partners to ensure the real-world voice of the customer is embedded into strategic planning to support innovation, business planning and field priorities. </li><li> Assist in the design and evolution of strategies accordingly to improve Launch Acceleration across Customer Engagement and the enterprise. </li><li> Ensure launch and operational excellence for priority brands and build standards that can be applied at an enterprise level for Customer Engagement. </li><li> Bring a novel lens to enterprise-level performance KPIs to gain new insights around the launch process and early market uptake, while partnering with analytics for metrics. </li><li> Support Sales Leadership to address issues and capitalize on opportunities specific to a product or therapeutic area in the launch period. </li><li> Deliver tailored solutions to individual launch scenarios while maintaining optimization through standard processes. </li><li> Ensures alignment to, compliance with, and ownership of all NPC policies, including the Code of Conduct and all applicable laws and regulations. </li></ul>Essential Requirements: <ul><li>Bachelor's degree in business, or related discipline. MBA preferred.</li><li>8+ years' experience in pharmaceutical, biotech, healthcare, or healthcare consulting industry, inclusive of at least 2+ different types of cross-functional roles/experience.</li><li>4+ years' experience in of experience on product launches in the Life Sciences Industry with 1+ years' experience in forecasting, product launch analytics, and/or BD&L.</li><li>2+ years' experience working in at least one of the following therapeutic areas: Immunology, Cardiovascular, Renal, or Neuroscience for any healthcare company.</li><li>Proven experience analyzing sophisticated situation and processes and effectively integrating and synthesizing the data to form a complete cohesive picture and actionable insights.</li><li>Experience in project management and translation of strategy into execution.</li></ul>Desirable Requirements: <ul><li>2+ years within a Healthcare Consulting Group.</li><li>Experience working in healthcare start-ups, with sales or sales operations experience.</li></ul>Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $192,000 and $288,000/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Company will not sponsor visas for this position. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Director, Customer Engagement Launch Acceleration - Remote

Summary This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10% travel. The Director, Go to Market Strategies will be responsible for crafting, developing, and leading core critical initiatives to improve customer-centricity and drive innovation across Customer Engagement that will have long lasting impact for customers and patients. This role will need to design for the future by identifying trends, opportunities, and risks internally and externally. The ideal candidate is passionate about healthcare forward approaches, new and emerging technologies and platforms, and insights and analytics required to help translate strategy into execution. This individual will play an integral role in driving alignment and cohesiveness of the enterprise strategy with a focus on deploying ground-breaking innovations and ongoing organization success. #LI-Remote About the Role Key Responsibilities: <ul><li> Accountable for developing and implementing the future Go-To-Market model for Customer Engagement working with key partners across almost every function within the US business. </li><li> Be forward-looking and drive strategies to enable the Customer Engagement organization to be future-proof." This includes but not limited to holistically understanding the strategic direction of the healthcare ecosystem, our customers, technology adoption and availability, and any other large external shifts that may impact our business. </li><li> Engage and collaborate with key Customer Engagement partners (Operations, Customer Engagement Leadership, and their Business Directors, etc.), and critical US cross-functional partners (other Field Leadership, Data Insights and Analytics, Marketing, Compliance, etc.) to identify and prioritize areas of strategic gaps and opportunities. </li><li> For implementation of any new initiatives, work with appropriate Customer Engagement and cross-functional partners to ensure skills training, sales methodologies, innovative technologies/tools & process improvements, standard methodology sharing, resource development are developed and driven consistently within Customer Engagement. </li><li> Provide recommendations and challenge leadership through ongoing analysis, insights, and strategies identified through impact assessment of launched tactics. </li><li> Build strong, cross-functional relationships to leverage Novartis' expertise to identify and address business goals and develop good understanding of our priority brands and their evolving needs. </li><li> Collaborates with Data, Insights & Analytics group to assess opportunities as well as the efficiency of our any implemented strategies. </li><li> Ensures alignment to, compliance with, and ownership of all NPC policies, including the Code of Conduct and all applicable laws and regulations. </li></ul>Essential Requirements: <ul><li>Bachelor's degree in business, or related discipline. MBA preferred.</li><li>8+ years' experience in pharmaceutical, biotech, healthcare, or healthcare consulting industry, inclusive of at least 2+ different types of cross-functional roles/experience.</li><li>2+ years' experience crafting, leading, and delivering sophisticated projects.</li><li>Demonstrated experience analyzing sophisticated situation and processes and effectively integrating and synthesizing the data to form a complete cohesive picture and actionable insights.</li><li>Experience in project management and translation of strategy into execution.</li></ul>Desirable Requirements: <ul><li>2+ years within a Healthcare Consulting Group.</li><li>Experience working in healthcare start-ups, with sales, sales operations, or marketing experience.</li></ul>Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $192,000 and $288,000/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Company will not sponsor visas for this position. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Director, Go to Market Strategies - Remote

About the Role #LI-Hybrid; #LI-Onsite On-site Hybrid 1,800+ associates. 85+ countries. 1 goal. At Novartis, we are dedicated to discovering and developing new treatments for diseases including cancer, heart disease, and neurological conditions-and delivering them at a scale to reach as many patients as possible. Novartis has a unique and promising portfolio with approximately 70 projects as potential NMEs in development, 52 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. And you could be at the center of it all in Regulatory Affairs (RA), where your voice, experience, and quality mindset can truly make a difference in drug development at Novartis. Read on to learn about the role available in RA. We hope you will consider joining our global RA family. The Sr Global Program Regulatory Manager will work independently under limited supervision to provide strategic and operational regulatory direction and may support the Regulatory Affairs Global Program Team (GPT) representative and/or Global Therapeutic Area Lead (GTAL) for programs through development, registration and approval/post approval. The Sr GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The Sr GPRM is a member of the RA sub team and may indirectly report to the RA GPT representative for the project and has responsibility for leading regional RA sub teams. Your Key Responsibilities: &bull; Provide input into global regulatory strategies and implement in assigned regions (focus US/LaCan) in collaboration with local teams &bull; Act as FDA liaison for assigned products &bull; Represent Regulatory Affairs and lead regulatory and cross-functional sub-teams &bull; Lead or coordinate Health Authority meetings &bull; Contribute to the development of global and local labeling and review of promotional and non-promotional material &bull; Ensure regulatory compliance, e.g. keep records of relevant Health Authority interactions in document management system and compliance databases Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements &bull; Science based BS or MS. Advanced degree (MD, Ph D, PharmD) preferred &bull; Prior experience in oligonucleotide or RNAi therapies preferred &bull; 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV, including experience in leading regulatory submissions and approvals in at least 1 major region &bull; Experience in a global/matrix environment or cross functional teams in the pharmaceutical industry &bull; Strong interpersonal, communication, negotiation and problem solving skills &bull; Proven ability to analyze and interpret efficacy and safety data Why Novartis? Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards. Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Compensation and Benefits Summary: The pay range for this position at commencement of employment is expected to be between $174,400 and $261,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Sr Global Program Regulatory Manager - AD Level (Cardio-Renal-Metab.)

About the Role Location: Onsite - Morris Plains, NJ Shift: Wednesday - Saturday 2:30pm - 1:00am Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. 365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives. Under general direction, perform testing and other activities in functions supporting the Quality Control department (Micro/EM, QC Bio-assay, and raw materials, as appropriate). &bull; Perform Bio-Analytical testing such as Flow, ELISA, cell count, cell viability, qPCR as well as micro/EM testing such as environmental monitoring, gram stain, sterility, endotoxin, and mycoplasma. &bull; Perform raw material testing such as HPLC, GC, FTIR, osmolarity, UV/VIS, polarimeter, refractometer, and viscometer. &bull; Maintain controls and reference standards to support testing. Maintenance of Cell Lines and cell banks. &bull; Review/approve data generated by other team members. &bull; Perform method qualification/optimization of methods as per appropriate protocols. &bull; Contribute to OOS/OOE investigations and deviation investigations. &bull; Knowledge of LabWare LIMS and/or other QC data systems. &bull; Maintain GMP/GLP quality systems and follows quality policies Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements &bull; BA or MS in chemistry, biochemistry, microbiology, or other related science AND 0 - 5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry. &bull; Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.). &bull; Knowledge of microbiological and environmental monitoring, bioassay, and/or raw material test methods, as appropriate. &bull; Knowledge of LIMS systems. &bull; Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations. &bull; Detail-oriented with expertise in problem solving and solid decision-making abilities. &bull; Strong written and verbal communication skills are essential. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture. The pay range for this position at commencement of employment is expected to be between $69,300 - $103,900 salaried; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Associate Scientist (Wed - Sat 2:30pm - 1:00am)

About the Role Location: Onsite - Morris Plains, NJ Shift: Sunday - Wednesday 7am - 5:30pm EVP: 365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives. The Scientist, Quality Control is an individual contributor role located in Morris Plains, NJ. The Quality Control Scientist will support patient throughput and compliance activities within the Quality department. Your responsibilities include, but are not limited to Patient Throughput &bull; Execute in-process and release testing on batches including, but not limited to, flow cytometry, IFNg potency, qPCR, cell count and viability, sterility, and endotoxin. &bull; Perform data review, generate Certificates of Analyses for release of final produce in accordance with company procedure Project Management &bull; Helps maintain progress of projects Compliance &bull; Ensures that all planned, executed, and documented activities are aligned with company and site objectives. &bull; Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations. Support of Quality partners &bull; Assists Quality Control, AS&T, and Quality Assurance in investigations of assay-related issues. &bull; Executes and supports transfer of analytical methods between AS&T-QC, to other Novartis sites, and to CMOs. &bull; Provides timely response to requests for support of manufacturing deviations, investigations and change requests. Other &bull; Performs or supports other tasks related to Quality and site operations, as needed &bull; Performs evaluation of new and existing analytical methods being transferred to or from the site by utilizing a risk-based approach. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements Requirements (mandatory: every candidate who is considered must have the qualifications described here. A candidate without these qualifications will not be considered or presented to the hiring manager) &bull; A minimum of a BA/BS in biology, chemistry, biochemistry, microbiology or other related science is required. &bull; At least 3 years of experience within pharmaceuticals of related testing laboratory is required &bull; Experience in Analytical Quality Control, method development, or a technical support function is required &bull; Demonstrated knowledge and skills in multiple analytical techniques is required &bull; Ability to prioritize and execute multiple tasks simultaneously under tight deadlines &bull; Strong verbal and written technical communication skills as well as strong interpersonal skill &bull; Detail-oriented with ability towards problem solving and solid decision-making abilities &bull; Strong written and verbal communication skills are essential as well as proficiency using MS Word, Excel, and MS project is required Desirable (not mandatory but are used to prioritize candidates who have described preferred qualifications but does not eliminate candidates from being considered) &bull; Understanding of ICH and FDA/EMEA GMP requirements &bull; Knowledge of cGMP, USP and FDA guidelines &bull; Knowledge of LIMS systems &bull; Knowledge of Quality Management Systems, such as Trackwise and 1QEM Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture. The pay range for this position at commencement of employment is expected to be between $97,600 - $146,400 salaried; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Scientist, Quality Control (Sun - Wed 7am - 5:30pm)

About the Role Location: East Hanover, NJ #LI-Hybrid Hiring for multiple roles. About the role: Love data management? Bring that passion to Novartis! This key Senior Principal Clinical Data Scientist will be responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality, and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s). Key Responsibilities: &bull; Provides DM leadership across assigned trial(s) and Program(s) ensuring strong DM representation across the CTT. Acts as an ambassador for CDAM across the organization, showcasing business value and benefits. &bull; Demonstrates a business understanding of the compound profile and data strategy to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i.e. ensuring consistency across data quality plans &bull; Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director &bull; Competent in relevant CDISC or other recognized industry standards and how these impact the programming team. Ensures consistency of program level standards &bull; Maintains awareness of the status of start-up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Ensures the key study risks & issues are shared in the Project Review Meeting led by Sr GHs/GHs. &bull; Provides accelerated feedback to assure well written, stable protocols and amendments. Recognize and resolve protocol issues that may impact database Diversity & Inclusion / EEO The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Role Requirements Essential Requirements: &bull; Bachelor's degree in life science, computer science, pharmacy, nursing or closely related discipline. &bull; 7 years' experience in Drug Development with at least 5+ years' in Clinical Data Management &bull; Demonstrated strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines &bull; Excellent understanding of clinical trials methodology, GCP and medical terminology &bull; Proven ability to interrogate and view data through various programming/GUI techniques. &bull; Must be able to anticipate challenges and risks and proactively suggest/implement solutions &bull; Ability to work under pressure demonstrating agility through effective and innovative team leadership &bull; Excellent interpersonal skills and proven ability to operate effectively in a global environment. &bull; Ability to influence and communicate across functions and to external stakeholders &bull; Understanding of project management concepts in order to aid delivery across a program &bull; Excellent oral and written skills Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network The pay range for this position at commencement of employment is expected to be: between $124,000 - $186,000; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Accessibility and reasonable accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Sr Prin Clinical Data Scientist (Prog Data Mgr)

About the Role We are seeking a highly motivated scientist and leader specialized in RNAi therapeutics to join the xRNA group within Biologics Research Center (BRC) in Cambridge, Massachusetts as Associate Director, xRNA. The xRNA group drives a diverse portfolio of pipeline programs and innovation to attenuate gene expression via RNAi. Through its design, screening and analytical capabilities the Cambridge xRNA group works collaboratively with Disease area groups, the Global Discovery Chemistry (GDC) group and the Discovery Sciences group to broaden the use of RNAi into new tissues outside the liver. As Associate Director of xRNA Therapeutics, you will have an opportunity to join the Biologics Research Center (BRC) as a leader at the cutting edge of innovative medicine development to improve patient lives. BRC builds the biologics pipeline in collaboration with Novartis Biomedical Research (NBR) Disease Areas and Platforms via a breadth of technologies for discovery of antibody, protein, gene therapy and RNA-based therapeutics. Your Key Responsibilities: &bull; Lead a team of approximately 10 highly talented scientists on the Cambridge site responsible to drive RNAi based therapies to patients via design, screening and characterization. &bull; Establishes mid- and long-term goals, plan of action and implementation for the local xRNA team (e.g. annual objectives) in line with BCR and NBR strategy and objectives. &bull; Develops and implements strategy for next generation extrahepatic RNAi for NBR. &bull; Co-leads RNAi drug development programs with partners in GDC and Disease Areas. &bull; Represents xRNA Therapeutics as the xRNA Site Head for the Cambridge site including handling the budget of the RNAi unit in collaboration with global counterparts in order to meet BRC targets. &bull; Ensures allocation of group resources according to portfolio and platform priorities. &bull; Sets strategy, implements and manages outsourcing for the local xRNA team. &bull; Collaborate with downstream development colleagues to bring lead candidates towards full development. &bull; Collaborates and coordinates activities with other global BRC and NBR units. &bull; Offer innovative approaches to scientific questions and troubleshooting efforts. &bull; Identifies Disease Area's unmet needs and collaborate for a novel therapeutic solution. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements Essential Requirements: &bull; PhD with more than 10 years relevant experience and recognized both internally and externally as expert in RNAi &bull; Prior experience with drug discovery focused on RNAi design, screening, and characterization &bull; Deep knowledge of RNAi chemistry and biology applied to lead optimization of therapeutic candidate &bull; A proven track record of success as judged by publications and patents &bull; Demonstrated ability to recruit, retains and develops diverse, and agile associates with different expertise, seniority and tasks to ensure long term talent development and talent pipeline including succession planning. &bull; Background in leading and mentoring a research group consisting of associates of all levels and acting as a manager of mangers &bull; Knowledge in the application of RNAi to biology in the areas of neuroscience, cardiovascular and renal metabolic diseases is required &bull; Highly collaborative spirit inside and outside of department to advance programs to clinic; good communication skills, creativity, and multi-tasking in a fast-paced environment. &bull; Excellent, oral and written communication skills, track record in scientific collaboration with a strong interest/potential in expanding beyond core science Desirable Requirements: &bull; Experience with extrahepatic targeting of RNAi is a preferred Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $151,200 - $226,800/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay conn Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Associate Director, xRNA Therapeutics

Site Name: USA - Massachusetts - Boston Posted Date: May 17 2024 Territory:Boston, MA and suburbs The GSK vaccines business is one of the largest in the world, providing more than 30 pediatric, adolescent, adult, and travel vaccines worldwide. GSK's vaccine heritage spans more than 100 years, beginning in 1882 with the manufacturing of smallpox vaccine. Vaccination is the most effective health intervention after clean water, preventing millions of deaths from infectious disease around the world every year. In the US, vaccination rates remain low among adults for vaccine-preventable diseases. Our ambition is to be a trusted partner in increasing immunization rates and protecting against vaccine-preventable diseases . This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: <ul><li>The Immunization Specialist will develop and maintain specialized expertise in vaccine therapeutic areas, products and markets</li><li>Demonstrate knowledge of GSK vaccines, competitive products and GSK promotional strategies and objectives in a way that meets customer needs</li><li>Demonstrate high-level selling and marketing skills, including account-based selling, strategic thinking, drive for results, and the ability to ask for the business</li><li>Demonstrate the ability to provide value to each targeted account through proper blending of science & service based upon each account's individual needs</li><li>Demonstrate the ability to effectively follow and use the vaccines sales process in a way that engages customers and ultimately leads to vaccines purchase</li><li>Collaborate with Vaccines partners, including PAMs, to help pull through GSK Vaccine doses</li></ul>Why You? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>4-year BA/BS degree from an accredited institution</li><li>2+ years business-to-business or pharmaceutical sales experience</li><li>Must live within territory (Greater Boston area, MA)</li><li>Valid driver's license</li><li>Must be able and willing to drive or operate a vehicle - driving is an essential function of this role.</li></ul>Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Minimum 2 years vaccines sales experience</li><li> Strong track record of high-level performance and consistent achievements </li><li>Nursing (MSN, RN, LPN) or other healthcare qualification and experience</li><li>Demonstrated competency of science, business acumen, and customer engagement</li><li>Strong account selling skills, including contract negotiations and ability to close a sale at the completion of a transaction</li><li>Strong track record of high-level performance and consistent achievements</li><li>Demonstrated learning agility</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Sr Acct Spec, Vaccines (MA - Boston)

Site Name: Cambridge Binney Street Posted Date: Mar 19 2024 GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. GSK has an exciting new opportunity for an experienced Process Engineer who will work closely with Manufacturing senior leadership to achieve department goals, interdepartmental manufacturing readiness, and batch release requirements. The Process Engineer is also responsible for owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to safety, quality, cost, on-time delivery, and right first-time performance. The Process Engineer supports by working cross-functionally with internal support departments and occasionally with external manufacturing to drive project completion. Key Responsibilities:<ul><li>Work independently to drive/own and cross functional team performance. </li><li>Develop a strong understanding of the manufacturing process and details of the associated hands-on operating requirements.</li><li>Learn complex concepts and communicate the information in a way that is engaging and understood by users.</li><li>Collaborate closely with SMEs and QA teams to create clear, concise, and technically accurate documentation.</li><li>Perform all tasks associated with Quality Record Management and Initiation and collaboratively resolve issues.</li><li>Own and manage Manufacturing process specific change controls, and CAPA's.</li><li>Author Minor and Major Deviation Investigations.</li><li>In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools.</li><li>Devises and implements CAPAs to address root cause and ensure effectiveness.</li><li>Collaborate with technical and operational stakeholders, writes and/or revises SOPs, batch records, technical reports, and other operational related documents if required.</li><li>Generate training material and conduct training for manufacturing staff.</li><li>Execute and collaborate with MFG and cross functional SMEs on Human Error Reduction CAPAs/Right First Time Initiatives.</li><li>Drive and own improvement projects that support department KPI's, with a focus on cost, innovation, on-time delivery, and quality. Manage projects from concept to completion; create and manage project plan, work cross- functionally and provide adequate training to impacted areas.</li><li>Generate and Manage Metrics.</li><li>Act as back-up to Manufacturing Management to perform Validation Protocol Review and approval.</li><li>Support the implementation of new processes in close collaboration with Program Managers, Process Transfer/Process Development, Engineering, MSAT, QA and Validation team.</li><li>Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.</li><li>Collaborate with engineering and validation teams to implement and qualify new equipment and controls.</li><li>Represent the interests of the Manufacturing team, serve in multidisciplinary project teams, working closely with other team members in a cooperative fashion to ensure project progression.</li><li>Be actively engage in Inspection Readiness activities and support internal and regulatory audits as needed.</li><li>Adhere to cGMPs is always required during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner for serious GMP deficiencies, process deviations, product defects and relevant actions.</li><li>Perform other duties and projects as assigned, according to the changing needs of the business.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>BS Degree in Engineering or equivalent technical discipline</li></ul><ul><li>3+ years of Biotech/Life Science/Pharmaceutical Biologics GMP Manufacturing related experience is required.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Facilitation and demonstration skills</li><li>Independent collaboration with outside resources</li><li>More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP) General knowledge of Quality/Regulatory GMP requirements in a biologics Pharma/ Biotech industry.</li><li>The knowledge, understanding, and application of cGMP's as it relates to Commercial operations.</li><li>Excellent written (especially technical writing), presentation and verbal communication skills.</li><li>Superior planning, time management and coordination skills and be able to readily adapt to changes in priorities and project schedules.</li><li>Attention to detail and good investigation, problem-solving skills.</li><li>Prioritize and deliver work in a fast-paced, deadline-driven environment.</li><li>The ability to adapt rapidly to a changing industry and be able to adjust responsibilities, time, and objectives accordingly.</li><li>Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint.</li><li>Very strong attention to detail.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Process Engineer

Site Name: USA - Montana - Hamilton Posted Date: May 17 2024 The Facilities Mechanic will a ssist Supervisor and Lead in performance of daily activities associated with routine and unscheduled maintenance. Responsible for the installation, set-up, preventative maintenance and repair of equipment associated with cGMP manufacturing operations. Comply with instructions on standard operating procedures and work instructions Please note this position may be for current hiring needs as well as pipelining potential talent for future vacancies. Communication may be limited until we have initiated an official recruitment process for this position. We appreciate your patience and hope to be in contact soon. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:<ul><li> Equipment Maintenance: Execute preventive maintenance plans and respond to site priority work as assigned by the Supervisor and Lead. Identify and help build critical spare part lists and improve maintenance plans and procedures. Focus on training and increasing competency in assigned areas. Work to increase equipment reliability and reduce equipment and production down time. The role will require stooping, standing and frequent lift of up to 50 pounds. Workers may be required to work shifts, weekends, holidays, overtime and carry an after-hours pager to respond to alarms on a rotational basis. </li><li> Environment Health & Safety : Responsible for application of GSK safety and environmental guidelines. Promote a safety culture; perform work in a manner to ensure safety of co-workers, equipment and self. Perform work that requires the use of LOTO, various PPE including respiratory protection and handling of chemicals. </li><li> Quality & Compliance : Ensure all activities are executed following procedures and GMP quality expectations. Comply with SOPs and departmental documentation requirements. Attend all mandatory training. Adhere to all GSK Quality Management System (QMS) policies and procedures as applicable for functional area. Ensure compliance and readiness for internal and external inspections and provide adequate support to inspected departments.</li><li> Accountability : Execute assigned work in a safe and timely manner. Escalate safety and compliance issues to the Supervisor. Support team and supervisor in completing high priority projects. </li><li> Operational Excellence : Provide support for continuous improvement initiatives and projects. Proactively identify opportunities for process improvements and presents ideas to process owner.</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li> 2+ years of experience in GMP manufacturing or equipment diagnostic and maintenance. </li><li> High School Diploma or GED.</li><li>Stooping, standing and frequent lift of up to 50 pounds. </li><li>R equires the use of a full-face respirator to perform certain job duties. </li><li>Be ing available of a rotating on-call schedule for after hours response. </li></ul>Preferred Qualifications:<ul><li> Possession of a Bachelor's Degree in science field or training/certification in a technical field. </li><li> Previous experience with clean utilities, process equipment and/or chemical handling is preferred as is any experience with pharmaceutical manufacturing. </li><li> Licensure and/or formal education in any related maintenance field. </li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Facilities Mechanic

Site Name: USA - Pennsylvania - King of Prussia Posted Date: Apr 18 2024 GSK is currently looking for QC Biochemistry Supervisor to join our team in Upper Merion, PA. The QC Biochemistry Supervisor provides first line supervision to QC analysts, who are responsible for in-process and BDS samples for release and stability testing. The Supervisor also serves as a leader outside of their immediate role in regard to testing and system optimization, driving continuous improvement, and participating in cross functional and cross business collaboration and teamwork. Key Responsibilities:<ul><li>Supervise a team of front-line QC Scientists. Performs administrative duties, i.e. hiring, performance management and supporting your team's development goals</li><li>Schedules and assures adherence to schedule for the performance of analytical testing for biochemical analysis, so that all testing to support the production and release of product lots is performed in compliance with internal procedures and standards and external regulatory standards.</li><li>Reviews and approves investigations, change controls, protocols, validation reports.</li><li>May review and approve biochemistry test results.</li><li>Writes, updates, reviews, and approves Laboratory Standard Operating Procedures and Analytical Methods</li><li>Evaluates new equipment for purchase.</li><li>Serves as point of contact for internal and external customers for analytical testing</li><li>Assures that laboratory equipment is calibrated and in good working condition, purchases supplies and equipment.</li><li>Utilizes GPS tools and processes to continuously improve efficiencies and leads problem solving for laboratory test problems.</li><li>Responsible for ensuring laboratories are operated in a state of control with regards to current LSOP's, GMP's and regulations and may serve as Biochemistry SME for internal and external regulatory audits and inspections.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>BS/BA degree</li><li>Minimum of 5 years' pharmaceutical experience in a GMP regulated environment</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Demonstrated supervisory and leadership skills with ability to hold team accountable.</li><li>Strong interpersonal and leadership skills. Solid team player able to function within team based organization.</li><li>Strong verbal and written communication skills.</li><li>Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.</li><li>Able to prioritize and decide appropriate course of actions. Effective at implementing decision.</li><li>Fully versed in cGXP, ICH guidelines, FDA, USP/EP/JP and data integrity guidelines and regulations for analytical testing and stability</li><li>Biopharmaceutical testing experience is preferred, ability to learn biopharmaceutical testing techniques. Assays include (but not limited to) - CGE, ELISA, CiEF, Bioassay, SEC, SPR, Protein Concentration, HPLC/UPLC, PCR, automated liquid handling</li><li>System experience preferred - SAP/ERP, LES, Webstatistica, Empower</li><li>Experience with MS Excel, Word, PowerPoint.</li><li>Strong organizational skills and task management skills.</li><li>Strong understanding of analytical methods.</li><li>Strong data analysis, trending, technical writing, and communication (verbal and written) skills.</li><li>Ability to solve problems.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

QC Biochemistry Supervisor

Site Name: Upper Merion, USA - Pennsylvania - Upper Providence Posted Date: Apr 18 2024 As a Sr. Safety Engineer, you will be responsible for the onsite safety of Upper Merion and Upper Providence R&D manufacturing areas by ensuring adherence to site safety programs and GSK standards, complying with process safety requirements, leading safety investigations, and continuously improving the site's safety culture. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include the following:<ul><li>Develop, review, and approve safety risk assessments for pharmaceutical manufacturing equipment.</li><li>Lead safety investigations for near misses and incidents to drive improved ways of working.</li><li>Facilitate creation and review of process safety documentation for R&D Pilot Plants (e.g., HAZID, PHA, ALARP, HAC, SIL).</li><li>Administer site safety programs such as PTW, LOTO, and contractor management.</li><li>Ensure GSK Engineering and Safety standards are followed.</li><li>Be the safety engineering voice during projects, in meetings, and at daily huddles.</li><li>Write / update site safety training.</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Undergraduate degree in engineering or life sciences, or an equivalent technical discipline.</li><li>5+ years of experience in pharmaceutical manufacturing.</li><li>Experience in pharmaceutical processing equipment.</li><li>Experience with process safety and occupational safety.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Familiar with cGxPs.</li><li>Technical understanding of industry / OSHA safety requirements.</li><li>Technical understanding of biopharmaceutical processing equipment.</li><li>Previous experience working as an EHS / safety engineer.</li><li>Ability to lead cross-functional teams through safety investigations.</li><li>Strong technical writing skills.</li><li>Strong verbal and written communication</li></ul>#LI GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Sr. Safety Engineer

Site Name: USA - Massachusetts - Cambridge, Collegeville TSA, USA - Massachusetts - Waltham Posted Date: May 17 2024 The Director External Innovation will be responsible to play a lead role in the development of new partnerships with external companies to progress precision medicine in specialty care space, leading cross-functional teams though evaluation and due diligence to support new opportunities and partnerships. Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Gain in-depth experience in the precision medicine specialty area (infectious disease, respiratory, vaccines, other) which is continuing to grow. The rapid approval of diagnostics in the specialty care space has paved a novel regulatory path for specialty disease areas like infectious disease/COVID-19.</li><li>Gain a cross-portfolio perspective and develop strategies that require systematic deployment of PM solutions to accommodate the competitive landscape in PM and propelled by the exponential innovation occurring in the PM space (technology advancement, multiplex biomarker development, utilization of AI/ML, development of novel & digital endpoints)</li><li>Contribute to development of precision medicine partnering strategy including (i) evaluation and recommendation of external companies to support novel technologies; (ii) new areas of science, including partnerships and collaborations in specialty area; (iii) ensuring alignment of precision medicine strategy with broader specialty vision and mission.</li><li>Support the Head of External Innovation in the following activities: (i) Identification, sourcing, outreach and assessment of innovative business and partnering opportunities for experimental and precision medicine in support of the GSK pipeline; (ii) Develop strategic plans to support the building of business cases for external Precision Medicine BD opportunities; (iii) Cultivate and grow GSK Precision Medicine partnerships with diagnostic and technology platform developers to support Specialty to advance research, clinical and/or commercial programs.</li><li>Tackle a wide range of projects and competent in working from early development through late-stage Precision Medicine opportunities. </li><li>Develop skills in leading matrix teams (ie. R&D, Commercial, Legal, BD, Finance, IP, etc) successfully through complex internal and external engagements and be ready to conduct impromptu and formal briefings with senior management (through the governance structure at GSK or otherwise)</li><li>Build capability of working across all levels of R&D and commercial for Precision Medicine. Working closely with Head, External Innovation, Experimental Medicine Unit, members of extended Precision Medicine LT, job holder will present External Innovation developed, proposals and opportunities to governance boards as required.</li></ul> Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: <ul><li>B.A. or B.S. degree in Life Sciences</li><li>5 or more years of pharmaceutical industry experience</li><li>5 or more years precision medicine experience in the Pharmaceutical/ Biotech industry</li><li>Experience in diagnostics, drug development, commercial processes and the application of PM/CDx tools</li><li>Experience with data analytical skills and ability to ascertain salient points from large amounts of information</li><li>Experience in strategic leadership - build commitment for current and future needs based on analysis of priorities, opportunities and risks</li></ul> Preferred Qualifications If you have the following characteristics, it would be a plus: <ul><li>M.S., Ph.D. in life science and/or MBA (Masters in Business Administration)</li><li>Good knowledge of governance procedures relevant to strategy development and deals, including BD (e.g. CDAs, Deal Flow, delegation of authorities, due diligence etc.)</li><li>Experience developing strategy and problem solving in drug development, pharma and translational scientific and medicine development (R&D), including oversight and delivery; experienced in working in an intense, rapidly evolving environment with an entrepreneurial approach to external relationships.</li><li>Demonstrated strategic thinking, ability to balance short and long-term goals; Proactive mindset that bridges ideas to realizable and deliverable solutions, and can help move both internal and external stakeholders to quickly solve problems</li><li>Proven ability to navigate multi-faceted organizations with repeated success; tenacity and resourcefulness, routinely capable of displaying a measured, proportionate and calm approach under pressure</li><li>Ability to set strategies/tactics that are aggressive, but realizable</li><li>Excellent interpersonal, communication, and presentation skills required - with demonstrated ability to communicate with senior leadership.</li><li>Personal integrity, teamwork abilities, collaboration skills and a customer focus are essential.</li><li>Wins followers with a positive and energetic approach to work and life.</li><li>Acts decisively and independently; must have confidence to provide clear direction to make strategic and tactical decisions and prioritize effectively. Knows when to seek leadership buy-in & guidance.</li><li>Drives accountability and empowers teams to make decisions to drive projects while knowing when to step in to remove obstacles and influence a course correction.</li><li>Flexibility and ability to work well with ambiguity and remain calm in intense situations</li><li>Gravitas and experience to create a positive relationship with third parties; customer focused - able to consider customers' (internal and external) needs while seeing the bigger picture" i.e. can customize support according to the priorities and needs</li><li>Must be able to uncover pivotal issues/opportunities and solutions</li><li>Previous scientific background to communicate critical specialty medical, scientific and business information and to positively influence internal & external stakeholders</li><li></li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Director, External Innovation Precision Medicine

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Ware, UK - London - Brentford Posted Date: May 17 2024 Job Purpose: Leads CMC regulatory activities in the global lifecycle management of GSK biopharmaceutical products. Management oversight for a team ensuring compliance with GSK policies and procedures, staff development and training to deliver roles. Key Responsibilities: <ul><li>Represents Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing and overseeing strategic direction and guidance to Supply Chain, Quality Assurance, 3rd Party Contract Management, Commercial and wider GRA on both global project and key strategic business initiatives. </li><li>Identifies key risks to the business associated with submission strategy and information packages and provides and communicates to senior management well defined risk mitigation strategies.</li><li>Likely to have direct line management responsibility. Coaches and mentors staff across CMC RA on lifecycle management in CMC.</li><li>Responsible for managing budget and resource for their teams. Responsible for team compliance with GSK policies and procedures, staff development and training to deliver roles.</li><li>Has effective organisational (internal and external) networks. Leads influences and motivates staff within and across departments.</li><li>Commercially astute and organisationally aware and able to deal with sensitive and confidential issues. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.</li><li>Delivers CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (LICs/PIRCs).</li><li>Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of the company. Leads the company position to influence the internal/external CMC Regulatory environment through specialist areas of intelligence.</li><li>Has accountability for submission content. Understands, interprets, and advises on regulations, guidelines, procedures, policies, and strategies relating to development, registration, and manufacturing of pharmaceutical products, to expedite submission, review, and approval of global CMC applications in alignment with regional requirements.</li><li>Directs resources (across multiple projects and teams simultaneously) to ensure all appropriate CMC regulatory aspects across teams to support license maintenance and change control requests including transfer of supply within the company or with a 3rd party are delivered to agreed timelines.</li><li>Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work.</li><li>Operates with independence. Directs and communicates complex regulatory issues independently at senior levels across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs ensuring optimum position for the company.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>BSc in Life Sciences or related scientific discipline with 5+ years of Post Approval CMC Regulatory experience for biopharmaceutical products</li><li>Experience in leading major post-approval filing activities for biopharmaceutical products (e.g. significant manufacturing change and key regulatory interactions in lifecycle management)</li><li>Experience in biopharm drug development and manufacturing and supply processes.</li><li>Experience working with complex worldwide CMC regulatory requirements.</li><li>Project management skills.</li><li>Effective influencing and negotiating experience with regulatory agencies, industry bodies, and personnel within the company in a variety of settings.</li><li>Experience handling complex global CMC issues through continuous change and improvement.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>PhD in Life Sciences or related scientific discipline.</li><li>Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines product support.</li><li>Demonstrated ability to influence the global internal/external regulatory environment in the biopharm space. </li><li>Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.</li><li> Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.</li><li>Identified as CMC Regulatory expert in a specific subject area.</li><li>Proven experience in supervising and training staff within and across the organisation.</li><li>Able to demonstrate the following key high-performance behaviours: customer driven, flexible thinking, and continuous improvement.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Director, CMC Regulatory Affairs

Site Name: USA - Pennsylvania - Upper Providence, Cambridge MA Posted Date: May 17 2024 GSK is looking for a dynamic Scientific Director to join their DMPK modeling group. As an individual contributor, the scientific director will have the opportunity to lead the development and implementation of MIDD (QSP, PKPD and PBPK) strategies within the DMPK modeling group. Along with other DMPK team members, they will collaborate across various cross-functional teams including biology, chemistry, clinical pharmacology, toxicology and formulations, contributing to the prediction of human efficacious dose across lead optimization and candidate nomination and contribute to internal dossiers & regulatory responses for small/large molecules and novel modalities. Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following. <ul><li>Work with global DMPK Leadership Team, wider modelling group and data sciences to deliver harmonised, cutting-edge modeling strategies, driving efficiency through software selection, App development and visualisations. </li><li>Support DMPK project representatives to identify and apply optimal modeling strategies and tools to support projects across discovery phases.</li><li>Independently build, validate, and apply models to support mechanistic understanding of absorption and systemic exposure potential for new chemical entities, biologics and new modalities.</li><li>Drive model informed drug discovery (MIDD) by providing valuable input into various DMPK assays, PKPD study design and clinical study protocols based on modeling outputs or requirements.</li><li>Utilise insights from relevant clinical data, through the application of modelling expertise to help direct preclinical drug discovery. </li><li>Provide valuable training and mentoring to support the development of existing and new staff together with the education of business partners.</li><li>Present modeling strategies and outputs in internal department meetings as well as external /international conferences.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>Advanced degree (PhD) in a relevant scientific discipline (Maths, pharmacology, biochemistry or other DMPK related science)</li><li>5+ years' work experience in related field or area of science </li><li>Experience in developing & implementing MIDD strategies across drug discovery and development phases. </li><li>Experience working with physicochemical properties and how it relates to drug disposition.</li><li>Experience in approaches and capabilities to conduct human PK and efficacious dose prediction.</li><li>Experience with DMPK scientific applications across drug discovery and development, including translational understanding of PK and PKPD.</li><li>Experience with peer-reviewed publication, public speaking / presentation</li><li>Track record of consortia engagement (e.g., IQ, ISSX, Acop)</li></ul>Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Excellent verbal communication skills.</li><li>Strong influencing skills across multiple formats including face to face and virtual project team environments.</li><li>The ability to work independently with excellent organizational and interpersonal skills</li><li>Demonstrated success in leading cross-functional small and large molecule drug discovery teams.</li></ul>#LI- Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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