- Lilly (Branchburg, NJ)
- …SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. + Ensure ... control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. + Assume SME leadership role for a specific… more
- Sokol Materials & Services (Skillman, NJ)
- …including plans, test protocols, summary reports, and traceability matrices, ensuring regulatory compliance and accuracy. * Investigate and resolve deviations ... Minimum of 3 years of experience in CQV and/or CSV within the pharmaceutical , biotechnology, cell therapy or medical device industries. + Experience with Cell… more
- Taiho Oncology (Princeton, NJ)
- …of contract service providers. + Comprehensive working knowledge of federal and international regulatory compliance pertaining to GMP + Ability to make decisions ... related to assigned cGMP manufacturers for a Taiho product/program and maintains compliance with global regulatory requirements and applicable filings. +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... data and external data, CDASH/SDTM, industry best practices, and relevant regulatory requirements is essential. This position demands significant skills in working… more
- Sokol Materials & Services (Skillman, NJ)
- …protocols, summary reports, and traceability matrices, ensuring technical accuracy and compliance with regulatory requirements. * Investigate and resolve ... degree is preferred. + Minimum of 7 years of CQV experience in pharmaceutical , biotechnology, cell therapy, or medical device industries, with at least 5 years… more
- Merck (Rahway, NJ)
- …launch in alignment with the company's business goals, and quality and regulatory compliance . **Essential Duties and Responsibilities:** + Utilize extensive ... all activities are conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional and local site… more
- Sanofi Group (Morristown, NJ)
- …providers and reimbursement. In this context, it is critical that pharmaceutical manufacturers generate and effectively communicate relevant real world clinical and ... + Maintain accountability for adherence to the publication SOP and other compliance expectations relevant to HEVA communication processes + Seek opportunities to… more
- Merck (Trenton, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... tools and framework for driving Go/No Go decisions on programs and rapid regulatory approvals + Foster collaboration within QP2 to achieve results, remove barriers… more
- Merck (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... analyses + Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory … more
- Bristol Myers Squibb (Madison, NJ)
- …to support development, and + Serving as principal functional author for Regulatory submission, study reports, and publications + Provides oversight and medical ... and other safety-related clinical considerations) + Fulfills GCP and compliance obligations for clinical conduct and maintains all required training… more