- Merck & Co. (Boston, MA)
- …the Clinical Director at this level will be expected to lead a Product Development Team (PDT) through late-phase clinical development and into post-licensure ... DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and… more
- Parexel (Boston, MA)
- …sponsor (ie: tasks and time per task contracted) and according to the assigned role ( Global Lead Physician GLP or Regional Lead Physician RLP). Medical ... our esteemed Medical Sciences Team and seeking an Associate/Medical Director to support the growth of our Global...including medical review of serious adverse events. - Support regulatory safety reporting activities - Ensure client needs and… more
- Curia (Boston, MA)
- …The Director , Analytical Development will provide technical leadership and lead a team of analytical scientists in support of biologics clinical development ... Director , Analytical Development in Hopkinton, MA Build your...has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over… more
- CSL Behring (Waltham, MA)
- …a hybrid position and is onsite three days a week. You will report to the Senior Director , Global Lead and Head Research and Clinical Bioanalytics. You will ... and implementation of bioanalytical/biomarker assays, ensuring scientific rigor, robustness, and regulatory compliance. ? Lead and provide oversight to the… more
- CSL Behring (Waltham, MA)
- …a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay. You will be part of a specialized non-laboratory based team and ... assays to support nonclinical and clinical studies. This role will lead the external tactical execution of bioanalytical/biomarker assays to ensure delivery… more
- CSL Behring (Waltham, MA)
- …hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay. You will part of a specialized non-laboratory based team and ... and biomarker assays to support nonclinical and clinical studies. This role will lead the external tactical execution of vaccine serology and biomarker assays to… more
- Nuvalent, Inc. (Cambridge, MA)
- …The Role: Reporting to the Director , Supply Chain Management, the Associate Director , Supply Chain Planning will build, lead , and execute end-to-end planning ... plans, ensuring supply continuity, and supporting strategic business objectives across global external manufacturing and partner networks. The ideal candidate brings… more
- CSL Behring (Waltham, MA)
- …position and is onsite three days a week. You will report to the Director of Clinical Assay. **Position Description Summary:** You will part of a specialized ... data sets to meet the business needs. Broad understanding of assay design, regulatory standards and industry best practices are essential. The incumbent will have a… more
- Jet Aviation (Bedford, MA)
- …In the hangar, on the ground, and behind the scenes. Enabling global flight, with passion. **Position Summary** The Assistant Maintenance Manager is responsible ... manager also maintains current technical proficiency and education of aircraft and regulatory requirements. The assistant maintenance manager reports to the Lead … more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as Associate Director , Global Regulatory Lead Oncology where you will ... be part of the global regulatory team. As Associate Director , Global Regulatory Lead Oncology, you will define and lead global … more
- Takeda Pharmaceuticals (Boston, MA)
- …to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Director , Global Regulatory Lead Oncology where you will be ... part of the global regulatory team. As Director , Global Regulatory Lead Oncology you will set global regulatory strategy and lead … more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead - Oncology, where you will ... readiness for high-impact oncology programs. **How you will contribute:** + Lead global regulatory strategy for assigned programs across development stages.… more
- Takeda Pharmaceuticals (Boston, MA)
- … Director will lead all submission types. + Accountable for building global regulatory strategies as defined within the GRT and ensure those are ... opportunities. + Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies on product specific… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter ... possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA… more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... for medical devices Due Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes the… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ready ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **OBJECTIVES/PURPOSE:** Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global ... system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the… more
- Takeda Pharmaceuticals (Boston, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... post-approval strategies for assigned products as GRA CMC Product Lead . + Represents and contributes to Regulatory ,...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **Job Title:** Associate Director - Analytics, Global Regulatory Affairs **Role Purpose:** Strategic ... the semantic layer and custom analytics capabilities in alignment with the Global Regulatory Analytics lead . + Working with primary Business Stakeholders to… more
