- 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
- Bristol Myers Squibb (Princeton, NJ)
- …Portfolio Management, global regulatory & safety, and global development operations ), and other functions (including research, commercialization, GPS, and enterprise ... functions within R&D (eg, Clinical Development) and across the Enterprise (eg, Operations , GPS, Commercial) + Engages senior leaders and functional area stakeholders… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production and submission of health authority documents ... expert in one or more key areas - Drug Development/ CMC /Pharmtox/ Biopharmaceutics/Clinical/Promotional. + Inter-dependent partnering skills, team-oriented and ability… more
- Integra LifeSciences (Plainsboro, NJ)
- …and set new standards of care. **SUMMARY DESCRIPTION** The Supervisor, Packaging Operations is responsible for the skin packaging production activities for CMC ... Sunday. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager , Manufacturing. **SUPERVISION EXERCISED** Directly supervises weekend first shift… more