- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business.- - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck & Co. (Rahway, NJ)
- …the business.- - Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven 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 of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… 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)
- …to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? The job is in ... and related delivery teams. May lead discussion at Global Regulatory Forum (GRF) or with senior management...maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- ThermoFisher Scientific (Wilmington, NC)
- …to high complexity, and may assume regional lead or Clinical Study Manager responsibilities. **Key Responsibilities** : + Manages all clinical operational and ... may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; eg process… more
- ThermoFisher Scientific (Morrisville, NC)
- …experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC , Regulatory or related compliance experience with at ... in the mission to holistically assess the state of quality and regulatory compliance across PSG global manufacturing/testing sites via fully independent audit… more
- Sanofi Group (Framingham, MA)
- …+ Project management skills **Preferred Qualifications:** + In-depth understanding of regulatory requirements for CMC analytical development + Expertise in ... **Job Title:** Senior Scientist, MSAT **Location** : Framingham, MA **About...cross-functionally within the Global MSAT organization and interfacing with Development/ CMC , Quality, Manufacturing, and external partners. We are an… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. ** Senior Director,** **Product Management** **Team** **Lead** **(Early Phase)** **_Location: ... within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director, Product Management Team Lead** will lead a team of… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge office. At ... experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability… more
- Merck (West Point, PA)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck (West Point, PA)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- ThermoFisher Scientific (Cambridge, MA)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **AD Project Management/ Senior Project Manager , Drug Development** At Thermo Fisher ... and communities depend on - now and in the future. **Position:** Associate Director/ Senior Project Manager , Drug Development, FSP **Location:** Fully Remote, US… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
- AbbVie (Irvine, CA)
- …(Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs, etc., and substantial ... project's primary point of contact for Pipeline Governance and senior management. + Has a broad vision for the...PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. +… 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. + ... cross-cultural experience. **Discover Impactful Work:** We are seeking a ** Senior Director, Project Management** in our **Oversight Respiratory Trials Team.**… more
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