- Organon & Co. (Jersey City, NJ)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides ... assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other...current global and regional trends in biopharmaceutical regulatory affairs . Proven effectiveness applying this knowledge… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …will report to the Senior Director , Strategy Lead of PAQ Oncology. The Director Medical Affairs - PAQ Oncology will support the US launch planning and ... treatment settings. **Key Job Responsibilities:** * In collaboration with global and US TA Medical Affairs , Managed...insights and evidence needs with the PAQ Oncology Medical Director * In collaboration with PAQ MS and cross-functional… more
- Sanofi Group (Morristown, NJ)
- …the IEGP. The Medical Director will collaborate with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to develop, ... **Job title** : Global Medical Director , Evidence Generation -...with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, ... or regions of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide… more
- Organon & Co. (Jersey City, NJ)
- …core labeling documents (CCDS) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU and ... updates to labeling tracking reports and databases, and provides status updates to Global Labeling management. + Provides regulatory expertise and guidance for… more
- J&J Family of Companies (Raritan, NJ)
- …including ensuring in-stream data quality from partners. + Work with colleagues in Regulatory Affairs to ensure that all relevant regulatory documents ... regulatory and clinical requirements for diagnostics development and commercialization, including global regulatory frameworks (eg, FDA, EMEA, PMDA). + Proven… more
- Ascendis Pharma (Princeton, NJ)
- …of TransCon-based products in other therapeutic areas and markets. Role Overview: The Senior Director of Global Marketing, Growth Disorders will be a key member ... decisions, and recommending market development and entry strategies. Additionally, the Senior Director will develop and implement the annual global marketing… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Medical Director , Immunology **Location** : Cambridge, MA, Morristown, NJ, **About the Job** This role reports into the Immunology ... medicines for chronic dermatologic, respiratory, rheumatologic, and gastrointestinal diseases. The Global Medical Director will lead the development and… more
- J&J Family of Companies (Raritan, NJ)
- …more at https://www.jnj.com/innovative-medicine We are searching for the best talent for the Director , Global Medical Affairs Strategy & Execution to be ... in Raritan, NJ. The Director , Global Medical Affairs Strategy...Medical Affairs directors, Janssen R&D clinical scientists, global and regional marketing directors, regulatory leaders,… more