- RWJBarnabas Health (West Orange, NJ)
- Senior Counsel, Assistant Vice President of Legal Affairs, Clinical Research & Regulatory ComplianceReq #:0000206242 Category:Professional / Management ... professional experience. Senior Counsel, Assistant Vice President of Legal Affairs, Clinical Research & Regulatory Compliance Job Overview: RWJBarnabas Health,… more
- Merck (Trenton, NJ)
- …+ Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory due diligence activities ... chemistry, or related discipline with 10+ years of relevant drug development, clinical , or regulatory experience. + MD or Ph.D./Pharm D with 7+ years of… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure ... Description: Regulatory expert in the area of Biosimilar/BLA submissions...of Biosimilar/BLA submissions including strategize, compile, review and manage/lead regulatory submissions. Subject matter expert in the area of… more
- Ascendis Pharma (Princeton, NJ)
- …years within Medical Writing. Furthermore, you have: + Experience in authoring clinical / regulatory documents. + Excellent verbal and written communication skills ... across time zones. + Ability to understand, interpret and communicate data from clinical trials. + Proven ability to work with and lead cross-functional, global… more
- Organon & Co. (Jersey City, NJ)
- …activity and complexity level, as well as post-approval products with limited clinical development + Regulatory product and compliance management (coordinates ... **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, Global… more
- Reckitt (Parsippany, NJ)
- …Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a ... Regulatory Affairs & Safety Associate, HH City: Parsippany...we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products… more
- Sumitomo Pharma (Trenton, NJ)
- …and tactical advancement of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical ... data analysis. + Provide medical expertise to cross-functional teams, including regulatory , commercial, and clinical operations. + Provide day-to-day practical… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is ... + Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy. + Working with experts and consultants in the field to… more
- IQVIA (Parsippany, NJ)
- …and close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference ... * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, ie, Good Clinical Practice (GCP) and International… more
- Merck (Rahway, NJ)
- …channels & decision-making processes between GCS and GCTO, including engagement with Clinical and Regulatory Organizations - communication channels + Monitor all ... of urgency and proactive approach to problem resolution + Understanding of regulatory frameworks in Clinical trials or clinical _supplies_ , GCP, GDP & GMP,… more