- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Sr Associate , Regulatory Affairs, CMC ** **Foster City, California** **Responsibilities:** + ... teams. + Develop, implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager . Participates in… 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 (North Wales, PA)
- …Research & Division organization of our company. ** ** **Position Description/Summary:** The GPAM Associate Director, Project Manager , is a core member of ... **Job Description** **Job Description:** The drug development Project Manager is part of Global...& Development pipeline and realize its full potential. The Associate Director is expected to provide project … more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director, Project Management Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... Summary We are seeking a highly skilled and motivated Associate Director, Project Management. The ideal candidate...with other functional areas including Clinical, Clinical Operations, and CMC . * Provide project management support for… more
- Verista (Norwood, MA)
- …new skills and learn from our experiences to enhance our collective expertise Associate Project Manager Responsibilities: Assessment of Digital QC Lab's ... SDMS System. Associate Program Manager will assist the Senior...Perform Study on path forward of SDMS within Moderna CMC Quality testing Labs: + Driver to implement SDMS… more
- Fujifilm (Holly Springs, NC)
- …Holly Springs, North Carolina, United States. **External US** **About This Role** The Associate Program Director (APD) is accountable for the planning & delivery of ... Quality Agreement, PPS, SOW) + Develops and maintains Master Project Plan (MPP) including accurate durations and accountabilities for...operations (DS / DP / FG) as well as CMC and regulatory aspects + Ability to lead, coach,… more
- System One (Florham Park, NJ)
- …In addition to these standard publishing requirements, the Senior Regulatory Operations Associate will bring project management skills and technical experience ... Senior Regulatory Operations Associate Contractor (Publishing) Must be local for Florham...implement Regulatory Operations' initiatives by attending and participating in Project Teams if deemed appropriate by manager .… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …true to the best of my knowledge. **Job Description** **Job Title** : Development Associate III **Location** : Brooklyn Park, MN **About the role:** As a Development ... Associate III, you will work with members of the...runs, process validation, data tracking and trending, and supporting CMC regulatory filings. You will report to the Sr.… more
- Amgen (Cambridge, MA)
- …the lives of patients while transforming your career. Contract Development and Manufacturing Manager **What you will do** Let's do this. Let's change the world. In ... Management + Occasional domestic and international travel to support project results + Performing other related duties and tasks...GED and 10 years of Manufacturing experience; Or + Associate 's degree and 8 years of Manufacturing experience; Or… more
- Novo Nordisk (Plainsboro, NJ)
- …to assist with overflow in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director. Works with personnel ... positive interactions with colleagues. Essential Functions + Therapeutic Area: + Assist Manager /Director in review of labeling for marketed products and new products… more
- Stantec (Denver, CO)
- …and industry experience to consistently produce project deliverables that meet project requirements, project manager and client expectations. Mechanical ... within project budgets and schedules to help project manager meet project financial...Strong knowledge of applicable codes and standards, including CBC, CMC , NFPA, and ASHRAE, as well as LEED, green… more
- Boehringer Ingelheim (Duluth, GA)
- …business, HR COE initiatives, and OPU initiatives. + Serves as the strategic project manager for key initiatives as assigned, ensuring the successful ... report to the HRD of Animal Health, the Senior Associate Director, HR Operations - AH is instrumental in...presentations for key and strategic stakeholders, including the AH CMC , AH Board, and during the Annual Discussion. +… more