- Sanofi Group (Morristown, NJ)
- …skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical ... of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The...organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device … more
- Merck (Rahway, NJ)
- …on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs, clinical operations, and CMC teams. + **Reporting & ... implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert...robust study design and high-quality PET data collection. + ** Regulatory support** : Familiarity with regulatory and… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project ... study protocols are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans. The Clinical… more
- Merck (Rahway, NJ)
- …worldwide. PCT leads process development as products enter Phase IIb through regulatory filings, process validation, and for several years beyond commercial launch. ... to commercial scale. Partners include research and development, analytical, regulatory , quality, packaging, and operations at our commercialization and commercial… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance, ... with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs, Finance, etc. of Tanabe Pharma Group, including external vendors… more
- Merck (Rahway, NJ)
- …state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ. This facility will be ... CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements. + Support and/or Direct Continuous Improvement projects with automation… more
- Bristol Myers Squibb (Princeton, NJ)
- …with drug development functions (including Strategy & Portfolio Management, global regulatory & safety, and global development operations), and other functions ... in the drug development process, especially late development space, relevant regulatory expectations, and overall drug development principles + Proven leadership… more
- Integra LifeSciences (Plainsboro, NJ)
- …Quality Inspector for the Plainsboro Manufacturing Site, Collagen Manufacturing Center ( CMC ). The lead associate is responsible for performing and/or scheduling ... 13485, the medical device directive, and the other applicable regulatory agencies. **This is for a Weekend Lead, the...of 5+ years' experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in… more
- Integra LifeSciences (Plainsboro, NJ)
- …Packaging Operations is responsible for the skin packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality ... to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all assigned employees are aware… more
- RWJBarnabas Health (Toms River, NJ)
- …37 West, Toms River, NJ 08755 Job Title: Food Service Worker Location: CMC Support Department Name: Dietary Management Req #: 0000208558 Status: Hourly Shift: ... areas according to standard practices and procedures while complying with regulatory requirements, ensuring that customer needs and satisfaction are met.… more