- Merck & Co. (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 ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.- - Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **:** The Manager , Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for ... provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC , and … more
- CSL Behring (Waltham, MA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . -Applies the CSL Leadership Capabilities - Build Bridges, ... therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? The job is in our Waltham MA… more
- United Therapeutics (Research Triangle Park, NC)
- …regarding CMC regulatory issues and provide strategic CMC regulatory interpretation and guidance to project teams + Actively manage and mentor junior ... for assigned projects. This role will collaborate with the manager , project teams, and functional area representatives...and functional area representatives to devise and implement sound regulatory CMC and labeling strategies. + Manage… more
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking a CMC Project Manager for a one-year contract opportunity with a leading biopharmaceutical company in South San ... Hybrid, onsite in South San Francisco, CA **Position Title:** CMC Project Manager **Position Type:**...operational excellence. You'll work closely with cross-functional leaders across CMC , Drug Development, QA, Regulatory , and external… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: CMC Project Manager ** **Location: Cambridge, MA (Hybrid)** **About the ... role:** As a CMC Project Manager , you will...& discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process. + knowledge, capability &… more
- BeOne Medicines (San Mateo, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior Manager ... in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an innovative and… more
- Teva Pharmaceuticals (West Chester, PA)
- CMC Biologics Quality Control Director, Physichemical Testing Date: Oct 17, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and stability testing, raw materials testing, contract lab testing, and regulatory submissions. The incumbent may also participate in/provide oversight of activities… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships ... Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate...(eg, GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- Merck (West Point, PA)
- …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 (West Point, PA)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- ThermoFisher Scientific (Cambridge, MA)
- …Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **AD Project Management/Senior Project Manager , Drug Development** ... communities depend on - now and in the future. **Position:** Associate Director/Senior Project Manager , Drug Development, FSP **Location:** Fully Remote, US _Our… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... depend on - now and in the future. Our Project Delivery colleagues within our PPD(R) clinical research services...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- ThermoFisher Scientific (Wilmington, NC)
- …consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, ... members involved in the study set up (DM, Reg, CMC etc ): ensure feasibility report are exhaustive, Review...activity timelines and metrics, providing status updates to the project manager , regularly reviewing projects using tracking… more
- Insight Global (Upper Gwynedd, PA)
- …deliverables, and resources. - Drive adoption and pilot execution for key regulatory processes (eg, marketing applications, PSUR, DSUR, CMC reviews), ensuring ... A large life sciences company is seeking a seasoned and strategic Program Manager to lead and manage a transformative Generative AI initiative, which involves a… more
- ERP International (Yuma, AZ)
- **Overview** ERP International, LLC is seeking a **Registered Nurse - Case Manager ** for a full-time position at the Camp Pendleton **Branch Health Clinic** in ... in Montgomery, AL and San Antonio, TX - plus project locations nationwide. ERP is an Equal Opportunity Employer...+ Maintain adherence to JCAHO, URAC, CMSA and other regulatory requirements. Apply medical care criteria (eg, InterQual). +… more
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