- Bayer (NJ)
- …of and adherence to US regulations, especially as they apply to compliance , to support labeling-related regulatory activities. Scientific and technical expertise ... in life sciences (or equivalent experience) with a minimum of 8 years pharmaceutical industry experience (preferably within regulatory functions) or MS degree in… more
- Robert Half Technology (Bridgewater, NJ)
- …for pharmaceutical functions such as R& D knowledge mining, regulatory intelligence, and medical information services. + Build and optimize data ingestion, ... AWS or GCP, ensuring adherence to data privacy and compliance standards (eg, HIPAA, GxP). + Collaborate with product,...or more in Experience working in R& D or regulatory settings within the pharmaceutical or biotech… more
- Bristol Myers Squibb (Princeton, NJ)
- …Committees + Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines + ... development plans in GU cancers. Responsibilities include support for IND preparation, regulatory authority interactions, design and execution of Phase 1 to Phase 3… more
- J&J Family of Companies (Raritan, NJ)
- …plants, both internally and externally. Cross-functional partnership with R&D, Quality, and Regulatory will be required to ensure processes meet the needs of today ... and robustness. + Lead the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans +… more
- Ascendis Pharma (Princeton, NJ)
- …and attention to detail + Knowledge of regulatory requirements and compliance standards relevant to pharmaceutical contracting, pricing, and rebate programs. ... . Maintain and review cross-functional files tracking contractual terms. . Ensure compliance with regulatory and contractual rebate requirements. . Collect and… more
- Organon & Co. (Jersey City, NJ)
- …impact of products to Organon's revenue, number and complexity of in-markets, regulatory history, historical performance (production and compliance ), new product ... + Ensure inspection readiness of the contract manufacturer and participate in regulatory and other quality and compliance report-outs; review audit outcomes… more
- Bayer (Whippany, NJ)
- …PRT execution process by ensuring all materials adhere to governance, legal, medical, compliance , and regulatory standards; + Collaboration with Global and USMA ... interpret medical/scientific data and develop strategic messaging and knowledge of pharmaceutical standards, compliance , and regulations; + Attention to detail… more
- Merck (Rahway, NJ)
- …development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising, ... and will advance a culture of scientific excellence and compliance with our company's procedures for recording time, data...field with 10+ years of relevant experience in the pharmaceutical industry; MS with 13+ years of relevant experience;… more
- Hovione (East Windsor, NJ)
- …as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. Our people ... services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities...practice. + Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …submit to regulatory agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety ... up. Establish the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements + Review...10+ years in PV & Medical Affairs in the pharmaceutical industry **Skills & attributes:** + Understanding of North… more