- 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
- Wells Fargo (Wilmington, DE)
- **About this role:** Wells Fargo is seeking a Senior Lead Business Execution Consultant as part of Consumer Banking and Lending in CMSPL. This role is in Product ... on Credit Cards. This individual will be a program manager , overseeing all Network rule and mandated changes that...implement information delivery or presentations to key stakeholders and senior management. + Lead the strategy and resolution of… more
- Bristol Myers Squibb (Devens, MA)
- …to ensure product quality, compliance and supply. + Author, review and approve regulatory CMC submission sections. + Drive continuous improvement initiatives to ... influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory , drug substance & drug product manufacturing, and… more
- Bristol Myers Squibb (Madison, NJ)
- …program goals in compliance with GCP, ICH and other global regulatory requirements + Provides comprehensive strategic leadership for 2,100+ multi-site organization ... experience (20+years) of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical trials and… 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
- ICON Clinical Research (Blue Bell, PA)
- …medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). Vendor ... Clinical Drug Supply Manager ICON plc is a world-leading healthcare intelligence...needed. Supports inspection team in preparation for and during regulatory agency inspection. Study Team Interaction + Represents Clinical… more
- Bristol Myers Squibb (San Diego, CA)
- …and mentor junior scientists and associates. + Documentation: Draft and review CMC sections for regulatory submissions, SOPs, and comprehensive development ... the design, development, and advancement of RayzeBio's radiopharmaceutical programs. This senior role is responsible for driving innovative research in novel isotope… more
- Bristol Myers Squibb (Devens, MA)
- … CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments. + Provides technical quality expertise and compliance oversight ... the commercial program (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program.The PQL must… more
- Sanofi Group (Washington, DC)
- …Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior manager of the TED team or Research lead, participates in project ... diseases and bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D… 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