• Senior Counsel, Assistant Vice President of Legal…

    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
    RWJBarnabas Health (07/04/25)
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  • Director/Principal Scientist, Regulatory

    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
    Merck (08/02/25)
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  • Associate Director Regulatory Affairs

    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
    Amneal Pharmaceuticals (05/16/25)
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  • Director, Quantitative Pharmacology,…

    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
    Otsuka America Pharmaceutical Inc. (07/16/25)
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  • Senior Medical Writer, Global Regulatory

    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
    Ascendis Pharma (07/17/25)
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  • Senior Analyst, Regulatory Program Manager

    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
    J&J Family of Companies (08/01/25)
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  • Associate Director, Global Regulatory

    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
    Organon & Co. (07/26/25)
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  • VP Clinical Development, Oncology

    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
    Sumitomo Pharma (05/15/25)
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  • Senior Director, Clinical Lead Alzheimer's…

    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
    J&J Family of Companies (07/22/25)
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  • Clinical Sciences Development Program…

    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
    AbbVie (08/03/25)
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