- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Manager , CMC Operations is responsible for independently managing technical ... transfer documents for Lilly and CMOs + Support the CMC team in ensuring that internal and external manufacturing...deployed products + Be a key resource for manufacturing operations and analytical troubleshooting at CMOs + Demonstrate a… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and budgeting of CMC resources to conduct monitoring oversight tasks. The Manager , Clinical Operations will also coordinate reporting and review of CRO ... **Job** **Summary** The Manager , Clinical Operations works closely with...manage monitoring oversight activities including managing Clinical Monitoring Consultants ( CMC ) contracted to perform monitoring oversight duties as well… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations , QC and Clinical Supplies Operations , and other Otsuka Companies,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations , etc.) to develop ... global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements,… more
- Parexel (Trenton, NJ)
- Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large, dedicated client team to drive impactful labeling operations ... markets. In this role, you will oversee end-to-end labeling operations across multiple markets, for Foundational (US, EU, CH,...* Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in… more