- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior … more
- Sanofi Group (Cambridge, MA)
- …GRA special initiatives. **About You** **Requirements** + Bachelor's degree, or equivalent, in regulatory affairs , the sciences, or related areas of study, and ... assigned programs at Sanofi. The Submission Lead is a senior team member with the expectation and accountability to...years of experience in the pharmaceutical industry, with direct regulatory affairs experience. + High degree of… more
- Sumitomo Pharma (Boston, MA)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... the Regulatory reviewer for assigned products. This position is responsible...eg Marketing and their Agencies, Legal, Compliance, and Medical Affairs . + Provide appropriate oversight of promotional material review… more
- Merck (Boston, MA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Astrix Technology (Boston, MA)
- …+ Collaborate with cross-functional teams, including preclinical, clinical operations, and regulatory affairs , to integrate and execute clinical strategy. + ... ** Senior Medical Director** Clinical Boston, MA, MA, US...Ensure clinical initiatives are aligned with organizational goals and scientific advancements. + Design and direct early-phase clinical trials,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies and optimize ... lead, mentor, and manage the MSAT team, fostering a culture of scientific excellence, collaboration, and accountability. + Provide senior technical leadership… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …and with cross-functional team members in scientific and clinical affairs , product development, regulatory , quality, and manufacturing. Essential Functions: ... It's a great time to be a part of ZOLL! Job Summary: As a senior engineer on our advanced development team, the successful candidate will contribute to the… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs , to develop and implement effective process ... their technical expertise to contribute across multiple projects, drive technical/ scientific strategy and mentor junior engineers. The Associate Engineering Fellow… more
- Sanofi Group (Cambridge, MA)
- …Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and/orTherapeutic Area Head to provide leadership, supervision, and coordination ... The GPH position requires achieving results through others and supporting the senior management team in achieving corporate goals. The GPH establishes the goals… more
- Takeda Pharmaceuticals (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). + Minimum of 5… more