- Sanofi Group (Cambridge, MA)
- …**Location:** Cambridge, MA / Morristown, NJ **About the job** The role reports to the Global Head of Hemophilia within the Global Medical Rare Disease ... This role will be responsible for the implementation of global medical strategy by working closely with global...and role model teamwork and collaboration. + Highest ethical, regulatory and scientific standards. **Why Choose Us** + Bring… more
- Chiesi (Boston, MA)
- …develops the clinical team personnel under their responsibility + Supports the Head of Clinical Development in coordinating the efficient planning and utilization of ... Medical Writers + Contribute to fostering and developing an environment of high- quality drug development and clinical excellence within GRD R&D + Provide clinical… more
- Bristol Myers Squibb (Devens, MA)
- …and reporting to maintain regulatory compliance. + Work collaboratively with Global Quality Governance and Performance Management Leaders to refine, monitor, ... operations-spanning development and commercial programs-meet or exceed regulatory and internal quality requirements. The Head of Cell Therapy Quality … more
- Merck (Boston, MA)
- …safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and ... **Job Description** Our Research & Development Division Quality Assurance (QA) is an independent organization that...significant deviation with projects/products, to the QAL and TA Head . + Interfaces and provides day-to-day support to applicable… more
- ConvaTec (Lexington, MA)
- …(Study Management, Site Management, Data Management / Data Analytics), Global Head of Clinical Operations, R&D, Regulatory and executive leadership as needed ... with applicable SOPs, guidelines, and regulations. + Working closely with the Global Head of Clinical Operations, develop study level operational strategy… more
- Sanofi Group (Waltham, MA)
- …of the job/major challenges** + (S)He interacts with other GBS teams, Clinical, Regulatory , Global Program Head , Regulatory , Immunology, Medical ... affairs plans, studies and submissions activities (when applicable), including quality , relevance to external stakeholders (eg regulatory authorities,… more
- CSL Behring (Waltham, MA)
- …and is onsite three days a week. You will report to the Senior Director, Global Lead and Head Research and Clinical Bioanalytics. You will lead a specialized ... and provide expert advice on bioanalytical and biomarker assays, data quality , regulatory expectations, clinic/submission readiness and associated risks.… more
- Takeda Pharmaceuticals (Boston, MA)
- …applications and interactions with regulatory authorities worldwide. + Assists the Global Medical Safety GI Therapeutic Area Head in assessing the ... (PSPV) team, you will report to the Vice President, Therapeutic Area Head of Gastrointestinal and Inflammation PSPV. You may manage/oversee physicians and Health… more
- Sanofi Group (Waltham, MA)
- …the supervision of the head of Preclinical or Non-Clinical Team and/or the TED Global head who are all part of the Global Biostatistical Sciences (GBS) ... the lead statistician and provides support, with minimal supervision from manager or TED Global Head , to the preclinical research team or non-clinical team on… more
- Bristol Myers Squibb (Cambridge, MA)
- …success filing regulatory dossiers and prosecuting them through approval + Global experiences is a plus since this position has responsibility for strategy and ... Clinical Development Program Leader sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug… more