- J&J Family of Companies (Raritan, NJ)
- …This position will partner with JJT-TS, EQ and business Segments to ensure that J&J Quality Standards and global regulatory requirements are met and will ... AI/ML, etc. This position reports solid line to the Head , JJRC Technology Regulatory Compliance within the...in managing all aspects of Quality and Regulatory Compliance in an international, global context,… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- …regulations and Glenmark GPV procedures + Track and report to the Regional Head any regulatory authorities or business changes impacting pharmacovigilance and ... America. The successful individual will be part of a Global team implementing and maintaining a PV system that...cases as well as monthly reconciliation activities + Support audit/ regulatory inspections and work closely with Regional Head… more
- Merck (Trenton, NJ)
- …safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and ... **Job Description** Our Research & Development Division Quality Assurance (QA) is an independent organization that...significant deviation with projects/products, to the QAL and TA Head . + Interfaces and provides day-to-day support to applicable… more
- Ascendis Pharma (Princeton, NJ)
- …their skills. The Associate Director, ICSR Management Team reports to the Director, Head , ICSR Management Team within the Global Patient Safety (GPS) ... PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits +… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …including but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development (late phase), ... Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head , reporting to the VP, Translational Medicine and Early Clinical Development within… more
- Taiho Oncology (Princeton, NJ)
- …and/or EU Regulatory authorities is preferred. + Highly detail and quality oriented. + Ability to learn, integrate complex information, and communicate clinical ... guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …The Director will be a key contributor to INDs, NDAs, BLAs, and other global regulatory filings and publications. The Director will foster relationships with ... + Designs, conducts, and reports clinical trials in line with the development, regulatory and global program strategy. Provides medical expertise in study… more
- Sanofi Group (Morristown, NJ)
- …the supervision of the head of Preclinical or Non-Clinical Team and/or the TED Global head who are all part of the Global Biostatistical Sciences (GBS) ... the lead statistician and provides support, with minimal supervision from manager or TED Global Head , to the preclinical research team or non-clinical team on… more
- Bristol Myers Squibb (Madison, NJ)
- …success filing regulatory dossiers and prosecuting them through approval + Global experiences is a plus since this position has responsibility for strategy and ... Clinical Development Program Leader sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug… more
- SMBC (Jersey City, NJ)
- SMBC Group is a top-tier global financial group. Headquartered in Tokyo and with a 400-year history, SMBC Group offers a diverse range of financial services, ... client base to local markets and the organization's extensive global network. The Group's operating companies in the Americas...this role, you will report to the Executive Director, Head of Compliance Training, and will be responsible for… more
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