- Merck & Co. (Boston, MA)
- …leverage advanced computational modeling and simulation tools to support pharmaceutical researchers in predicting drug behavior, improving decision-making, and ... biological, pharmacokinetic, and pharmacodynamic systems.Primary Responsibilities: Problem discovery and strategy In close partnership with our Research & Development… more
- Merck & Co. (Boston, MA)
- …QP2 -IO on Oncology development teams. Framing critical questions and strategy for optimizing model-based analyses on programs. Developing and executing model-based ... tumor size and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring … more
- Lundbeck (Boston, MA)
- … Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress… more
- Fresenius Medical Center (Waltham, MA)
- …of high-quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global ... the pharmaceutical industry. + Proven experience in leading global regulatory strategy for complex pharmaceutical products across multiple regions (FDA,… more
- Takeda Pharmaceuticals (Boston, MA)
- …This role serves as the single point of contact for R&D CMC Portfolio Strategy enabling activities on behalf of the CMC community within R&D, but also in ... office), portfolio insights and portfolio stakeholder management. + **R&D CMC Strategy Leader & Stakeholder Management:** Accountable for oversight of the Pharm… more
- AbbVie (Waltham, MA)
- …. Job Description The Director, Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the... experience. Some portion may include experience related to pharmaceutical regulatory work (eg, other R&D role… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the ... development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports,… more
- Cardinal Health (Boston, MA)
- …who provide consulting services in a myriad of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry ... Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance + Product Lifecycle Management +… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + 7-years CMC regulatory experience in the pharmaceutical industry with a history of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (eg, technical regulatory strategy documents, storyboards, risk ... to drive organizational evolution. + Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support… more
