- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …Relationship/Scope: + This position reports to the Head of Global Medical Affairs . The Senior Medical Director will interact with internal colleagues in the ... Medical Department, Marketing, Sales, Research and Development, strategy/portfolio management, Regulatory Affairs , and Pharmacovigilance. External collaboration includes… more
- J&J Family of Companies (Titusville, NJ)
- …Team leadership via matrix interactions includes individuals from TA strategy, GCSO, global regulatory affairs , project management, finance, legal, quality ... Leadership, Medicines and Device Development and Regulation, Program Management, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- Sanofi Group (Morristown, NJ)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge, MA **About the...boards + Serves as clinical team leader/representative at the global project team(s), regulatory agency meetings, Steering… more
- J&J Family of Companies (Raritan, NJ)
- …Market Surveillance, Clinical Affairs , Design Quality Engineers, R&D, and Regulatory Affairs relating to literature search and systematic review processes. ... Experience within the medical device industry and with clinical evaluation report regulatory requirements **required** ; thorough understanding of global medical… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …programs from initial feasibility through full-scale commercialization. + Partner with global regulatory (clinical and CMC) for developing combination products ... with evolving requirements across FDA, EMA, PMDA, and other global authorities. + In concert with CMC RA...advanced degree. Regulatory Expertise: Direct experience with global regulatory submissions and agency interactions for… more
- Merck (Rahway, NJ)
- …marketing teams within the organization along with sales, product development, regulatory affairs , customer service, and other cross-functional teams to ... skills and ability to successfully partner cross functionally with all business units, regulatory , legal, and with Global Marketing colleagues + Demonstration of… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Manufacturing and Controls (CMC), medical affairs and business development are critical to the success...to inform mitigation strategies in accordance with regional and/or global regulatory requirements. + Actively participate in… more
- J&J Family of Companies (New Brunswick, NJ)
- …of degree is required. Advanced degree in management, EHS technical field or regulatory affairs , preferred. **Other:** An advanced degree MS or MBA preferred. ... **Position Summary** Reporting to the Chief Sustainability Officer, the Senior Director , Enterprise Safety Solutions leads the strategic development and delivery of… more
- J&J Family of Companies (Titusville, NJ)
- …Finance and Procurement, Global Commercial Strategic Organization, Global Medical Affairs , Regulatory Affairs , Research & Development, Global ... Medical and Scientific Communications Teams, US commercial partners, Cross US Medical Affairs Therapeutic Areas, Global Clinical Development Organization,… more