- Novo Nordisk Inc. (Plainsboro, NJ)
- …may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate ... ready to make a difference? The Position The Medical Director serves as the subject matter expert for our...interface with key stakeholders across CMR, Marketing, and the Global organization to drive scientific exchange and communication with… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- Drive Labeling Strategy , in-line with overall global regulatory strategy , by providing labeling expertise for Company Core Data Sheet (CCDS), USPI ... negotiation strategies. + Support global HA interaction strategy to discuss key labeling elements. +...facilitate final label negotiations and approval. + Present to Global Labeling Review Team: Ensure Core Data… more
- Bristol Myers Squibb (Princeton, NJ)
- …CI insights) into the integrated development plan, including, clinical plans and labeling strategy ; Appreciates translation of clinical data into claims and ... and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Global Program Leads within the ICV Global Program Leadership… more
- Merck (West Point, PA)
- …with worldwide regulations, company policies and standard operating procedures. The Senior Director , Global Label Operations, is a strategic multi-team leader ... **Job Description** The Global Clinical Supply (GCS) organization within our Research...External Collaborations). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical… more
- Ascendis Pharma (Princeton, NJ)
- Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs ... Sciences team for the US business, the Associate Medical Director supports the US Medical Director for...and implementation of the product medical and medical launch strategy as well as working intricately within the other… more
- Sumitomo Pharma (Trenton, NJ)
- …for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based ... regulatory activities for assigned project(s) in line with the global registration strategy of the product +...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- J&J Family of Companies (Titusville, NJ)
- …via matrix interactions also includes individuals from project management, TA strategy , global regulatory affairs, finance, legal, quality assurance, quality ... for humanity. Learn more at https://www.jnj.com/. **POSITION SUMMARY:** The Senior Director , Clinical Leader (CL) is responsible for development and execution of… more
- Merck (West Point, PA)
- **Job Description** The Global Clinical Supply (GCS) organization within our company's Research Laboratories (manages the end-to-end clinical supply chain for the ... and 200+ External Collaborations). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites across more… more
- Merck (West Point, PA)
- **Job Description** The Global Clinical Supply (GCS) organization within our company's Research Laboratories manages the end-to-end clinical supply chain for the ... and 200+ External Collaborations). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites across more… more
- GRAIL (Trenton, NJ)
- …North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, ... please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with...to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs… more
- Ascendis Pharma (Princeton, NJ)
- …passionate about patient safety and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced Program Safety ... Lead to champion safety excellence, drive compliance, and shape strategy across our growing portfolio. We are a dynamic,... across our growing portfolio. We are a dynamic, global biopharmaceutical company headquartered in Denmark with hubs in… more
- Ascendis Pharma (Princeton, NJ)
- Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs ... Act; and implementing regulations promulgated by the FDA pertaining to drug labeling and the advertising and promotion of pharmaceutical products. + Draft, negotiate… more
