- 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 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
- Merck (Trenton, NJ)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... Support device design control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices and combination products,… 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
- 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
- Sumitomo Pharma (Trenton, NJ)
- …Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains… more
- Taiho Oncology (Princeton, NJ)
- …Taiho such as: Clinical Development, Commercial, HEOR, Market Access and Regulatory Affairs , Patient Advocacy, TOE, TPC and global teams to ensure as needed ... Medical Director , Medical Affairs Princeton, NJ, USA...we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other.… more
- Sumitomo Pharma (Trenton, NJ)
- …, Medical Strategy (Women's Health) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties… more
- Bristol Myers Squibb (Princeton, NJ)
- …Collaboration : Serve as the primary point of contact for internal (Medical Affairs , Development, Commercial, Regulatory Affairs , Legal, and Compliance) and ... record of successfully developing, centralizing and managing MAPs across a portfolio. + Regulatory / Compliance Knowledge: In-depth knowledge of global and local… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Regulatory Project Management and Strategic Planning - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Ascendis Pharma (Princeton, NJ)
- …offer a dynamic workplace for employees to grow and develop their skills. The Director , Global Head of Publication Planning is responsible for leading the ... phase through the full lifecycle of Ascendis' products. The Director will manage a successful team of writers and...Responsibilities + Serve as key member of the Scientific Affairs organization, within Global Medical Affairs… more
- Bristol Myers Squibb (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Director Global Policy and Business Strategy Integration is ... externally. ** Global Perspective:** ability to navigate in complex global regulatory , policy and business environments. **Strategic Thinking:** Understands… more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Integra LifeSciences (Princeton, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The Director , Global Regulatory Labeling is responsible for overseeing the ... regulatory affairs and quality assurance and working knowledge of global regulatory labeling requirements in key markets/geographies. + Ability to… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Ascendis Pharma (Princeton, NJ)
- …, Clinical Development, Clinical Operations, Compliance, Pharmacovigilance, Biometrics, Global Communications, and other functional group contributors to ensure ... Medical Director Do you want to be part of...both internal and external audiences within legal, compliance and regulatory guidelines. + Represent Ascendis Medical Affairs … more
- Sumitomo Pharma (Trenton, NJ)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The **Executive Director Head of Medical Strategy** will be a key… more
- Taiho Oncology (Princeton, NJ)
- …oncology, the Director , External Research will enjoy collaborating with Medical Affairs Product Leads on development of the areas of interest, execution of ... Director , External Research Princeton, NJ, USA Req #405...we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other.… more
- Novo Nordisk (Plainsboro, NJ)
- …the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... About the Department Our East Coast Global Development Hub brings together the best minds...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive… more