- Genmab (Plainsboro, NJ)
- …and related patient information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr ... and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for… more
- Merck & Co. (Lower Gwynedd, PA)
- …Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… more
- Genmab (Plainsboro, NJ)
- …the needs of the US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other ... authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors... strategic and tactical planning in coordination with the Global Medical Affairs and other cross-functional teams.Represent… more
- Merck & Co. (North Wales, PA)
- …Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation, and other global regulatory requirements that impact IT systems in the R&D and ... and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- Product managers must possess… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent,… more
- Merck & Co. (North Wales, PA)
- …Teams, Regional Product Directors, country affiliates, Global Market Access, and Global Medical and Scientific Affairs to ensure outcomes research programs ... Job Description Director , Outcomes Research Vaccines Position Description Under the guidance of Executive Director , the incumbent has the primary… more
- Genmab (Plainsboro, NJ)
- …this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams (and ... in particular security architects and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs , VP Regulatory Affairs , GM Genmab US, IT Lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Partnerships and Engagement, Customer Experience and Marketing Enablement, Employee Experience, Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, Launch ... Expert understanding of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well as the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs , Patient Safety required A thorough understanding and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department… more
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Associate Director , Global Regulatory Affairs ? The job is located in ... is a hybrid position. You will report to the Director of Global Regulatory Affairs . **Responsibilities:** You are a member of a Regional Therapeutic Area… more
- Merck (North Wales, PA)
- **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global ... business standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …understands probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Sumitomo Pharma (Trenton, NJ)
- … Regulatory Affairs ** . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs + Include the qualifications preferred… more
- Sumitomo Pharma (Trenton, NJ)
- … Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Taiho Oncology (Princeton, NJ)
- … regulatory affairs management, the incumbent independently prepares and directs global regulatory affairs activities and provides regulatory ... Associate Director , Regulatory Affairs Strategy...Performance Objectives: + Independently directs as well as prepares global regulatory affairs strategies and… more
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for a Global Medical Affairs Leader (GMAL), Director - Dermatology in our Immunology Global Medical Affairs ... potential. At Johnson & Johnson, we all belong. The Global Medical Affairs Leader (GMAL), Director...Excellent knowledge of study execution, benefit risk management and regulatory affairs highly preferred + Proven ability… more
- J&J Family of Companies (Horsham, PA)
- Johnson and Johnson is recruiting for a Global Medical Affairs Leader (GMAL), Director - Gastroenterology within our Global Immunology Medical Affairs ... GMAL - Gastroenterology (GI), under direction of the Head Global Immunology Medical Affairs - Gastroenterology, is...execution, data analysis & review, benefit risk management and regulatory affairs is highly preferred + Highly… more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Merck (West Point, PA)
- …Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… more
- Sumitomo Pharma (Trenton, NJ)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...member of the Medical Affairs team reporting to the Executive Director ,… more
