- 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 (Rahway, 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. + MS with 10+ years of experience. + Ph.D. with… 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
- 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
- J&J Family of Companies (Titusville, NJ)
- …project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, ... on development plans or program-related issues + Working with global clinical operations, Regulatory , and Global Medical Safety, leads the clinical team… more
- Bayer (Whippany, NJ)
- … trials. This will involve collaboration with clinicians, clinical operations, bioanalysis, biomarker specialists, pharmacometrics, pharmacovigilance, regulatory ... + Lead and manage the preparation of the CP sections of major clinical and regulatory documents (eg CTDs, NDAs, INDs, IMPDs) and provide global CP submission… more
- Pfizer (Peapack, NJ)
- …informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical ... abstracts and/or presentations. + Solid understanding of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-… 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