- 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 ... alignment with regulatory trends, innovation, and compliance while balancing business benefits and risks. + Lead and Manage Global Submission Activities: Oversee… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …them into clinical development plans to support drug development and regulatory packages **.** + Lead ** clinical pharmacology** activities related to study ... performed and presented. Author PK reports that are integrated into clinical and regulatory documents. + Lead development of ** clinical pharmacology**… 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
- J&J Family of Companies (Raritan, NJ)
- …with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs, Project Management, Medical Writing, Clinical and other key functions ... regulatory requirements is preferred. + Experience working with clinical and/or regulatory teams in the early development space highly preferred. + Project… 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
- AbbVie (Branchburg, NJ)
- …for each product partner with cross-functional team members from R&D, Operations, Clinical , Regulatory , Marketing, Project Management and more to oversee User ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description AbbVie's Clinical Sciences Development Program - Medical Device consists of three… more
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