- Bristol Myers Squibb (New Brunswick, NJ)
- …that produce finished packaged clinical supplies while ensuring and maintaining compliance with all quality requirements. + Reviews the master production schedule ... relevant experience may substitute + 5+ years in a pharmaceutical industry preferably pharmaceutical manufacturing with a...is required. + Strong working knowledge of cGMP's and regulatory (ie, FDA, EU, OSHA, etc.) requirements and their… 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 ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… more
- Merck (Rahway, NJ)
- …leverage advanced computational modeling and simulation tools to support pharmaceutical researchers in predicting drug behavior, improving decision-making, and ... experts as necessary to facilitate progress. + Actively participate in regulatory audits and inspections in close collaboration with business stakeholders and… more
- Astrix Technology (New Brunswick, NJ)
- …ensure robustness and reproducibility. + Prepare technical reports and documentation in compliance with regulatory requirements. + Support QC studies and process ... Our client who is a specialized CDMO within the pharmaceutical industry is looking for a seasoned Chemist to...Experience in HPLC method development + Strong knowledge of regulatory guidelines such as GMP + Excellent problem-solving and… more
- Bristol Myers Squibb (Princeton, NJ)
- …verbal and written + He or she should have an understanding of pharmaceutical drug development including clinical development, regulatory , life cycle management ... research (HEOR) to ensure accuracy, currency, scientific balance and compliance with internal policies and procedures. **RESPONSIBILITIES** + Maintains significant… more
- Teva Pharmaceuticals (Edison, NJ)
- …Oversee and participate in factory acceptance testing and commissioning support, ensuring compliance with company and regulatory standards. + Collaborate with ... OSHA and related federal, state and local laws, codes, regulations and regulatory requirements + Knowledge of pharmaceutical manufacturing operations to support… more
- Sanofi Group (Morristown, NJ)
- …+ Demonstrate accountability for all necessary and appropriate Sanofi legal, regulatory , and compliance review of communication materials, research or ... scientific professional for US Medical Affairs division of North American Pharmaceutical Operations. The Transplant MSL shares scientific and clinical data… more
- Bristol Myers Squibb (Madison, NJ)
- …& Experience** **Specific Knowledge, Skills & Abilities:** + Expertise in GMP compliance , global regulations and strong understanding of pharmaceutical product ... Demonstrated decision making and problem-solving capabilities relative to Quality, compliance , technical considerations, and regulatory requirements are… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …quality record owners to ensure documentation is accurate, complete, timely, and compliance to meet Health Authority and Otsuka processes. Responsible to collect ... for trends and notify management of events requiring and immediate action. + Identify compliance gaps and lead focused teams to resolve compliance issues. +… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …is pivotal in optimizing distribution partnerships, maximizing contract value, ensuring regulatory compliance , and supporting organizational access and revenue ... scorecards to evaluate contract effectiveness + Ensure all contracts meet legal, regulatory , and compliance requirements + Monitor and optimize gross-to-net… more