- AbbVie (Irvine, CA)
- …(Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs, etc., and substantial ... Asset Plan and PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. + Ensures that the AST… more
- Catalent Pharma Solutions (Kansas City, MO)
- …Management Systems (QMS) to assure the site/division is compliant with regulatory , Corporate, and customer requirements. They are responsible for establishing and ... business partner to Operations and advisor to the General Manager of the site. Location: Kansas, City, MO on-site...as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and… more
- AbbVie (North Chicago, IL)
- …and execution of device and combination product industrialization programs. The program manager is to provide strategic oversight for one or more industrialization ... use their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business objectives into actionable program… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... engages as appropriate in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing expertise and perspective… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... engages as appropriate in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing expertise and perspective… more
- Cambrex High Point (High Point, NC)
- …of the industrial regulatory landscape; Good understanding of site SOPs and regulatory CMC concerns and can answer client questions that can help to ... principles of cross-functional departments, including analytical chemistry and engineering. GMP/ Regulatory Knowledge: Demonstrated understanding of the GMP landscape and… more
- Takeda Pharmaceuticals (Boston, MA)
- …experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more
- Sanofi Group (Northborough, MA)
- …requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions + Knowledge and experience with ... coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations *...Reporting of deviations to coverage targets to Critical Material Manager (GSP) + Reviews SAP requisitions or Site Scheduler… more
- RWJBarnabas Health (Toms River, NJ)
- …world-class medical treatment with the comforts of hometown care. Opened in 1961, CMC has evolved into the state s newest teaching hospital with four residency ... system within the scope of practice defined by the Nurse Practice Act and regulatory standards and assures awareness of ethical standards of practice as defined by… more
- Merck (Rahway, NJ)
- …Managers in Value & Implementation (which is this job), Development, and CMC ; Discovery Portfolio Managers; Alliance Managers; Project Management Office (PMO); and ... **Position Description/Summary:** The GPAM Associate Director, Value & Implementation Project Manager (VIPM), is a core member of Value & Implementation (V&I)… more