- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Control Teams ( CMC ) to enable R&D Development Team objectives/deliverables. **Position:** Senior Manager , CMC Project Operations **Location:** New ... appropriate allocation of DS and API materials for non-clinical use. + The CMC Project Manager may co-lead and/or contribute to Product Development portfolio… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy...Leads US FDA/EU EMA interactions with support from higher-level manager . + **Regulatory Knowledge:** Demonstrates expert knowledge of US/EU… more
- Merck (Rahway, NJ)
- …arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck (Rahway, NJ)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs...preferred. + At least 8 years of experience in project management. + At least 5 years of experience… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply ... but not limited to, Clinical Operations, Chemistry, Manufacturing and Controls ( CMC ), Product Quality Assurance (PQA),Regulatory Affairs and Sourcing departments. +… more
- System One (Florham Park, NJ)
- …for process improvements. In addition to these standard publishing requirements, the Senior Regulatory Operations Associate will bring project management skills ... Senior Regulatory Operations Associate Contractor (Publishing) Must be...implement Regulatory Operations' initiatives by attending and participating in Project Teams if deemed appropriate by manager .… more
- Merck (Rahway, NJ)
- …Global Human Health (GHH) brand/ franchise commercial goals. The Biologics VCM Product Manager (PM) works under direction of the VCM Product Leader supporting the ... for one or more Biologics products. The VCM Product Manager will be responsible for supporting supply chain design,...key investments across the product supply chain, assure key project execution, and drive year on year attainment of… more
