- 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
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Summary** Head of the Global Development Operations function, accountable to lead an integrated, end to end global ... clinical operations function accountable for acceleration and delivery of clinical...of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical… 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