- Takeda Pharmaceuticals (Trenton, NJ)
- …activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders and ... to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is...external CRO partners such as Global Regulatory Compliance, Global Labeling,… 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
- 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
- Sumitomo Pharma (Trenton, NJ)
- …, Medical Strategy (Prostate Cancer)** 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
- Sumitomo Pharma (Trenton, NJ)
- …. **Job Overview** Associate Director , Field Medical and Scientific ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner.… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Merck (Trenton, NJ)
- …up with the latest regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and ensure submission readiness in all ... **Job Description** The Executive Director , Device Quality & Regulatory will...emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as… 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …Liaise with and advise study teams including Clinical Science, Data Management, Regulatory Affairs , and other functional areas locally/globally on matters ... of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements. + Good cross-cultural understanding and… 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
- 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
- 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...Non-Clinical Research, Medical Writing, Program Management, Product Supply and Regulatory Affairs teams to deliver and drive… more
- Edwards Lifesciences (Trenton, NJ)
- …healthier lives. Join us and be part of our inspiring journey. As the ** Director , Clinical Affairs (Clinical Data & Evidence Strategy),** you will be responsible ... portfolio. Support business growth and collaborate with stakeholders in Medical Affairs (including scientific communications) Global Health Economics and… more
- Novo Nordisk (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 (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global Safety Scientists and… more
- Novo Nordisk (Plainsboro, NJ)
- …maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs , Patient Safety required + A thorough understanding ... 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
- Novo Nordisk (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... and external stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director /Senior Director - Safety Surveillance, US East Coast… more