- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The Senior Director (Sr. Principal Scientist ) has...pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior … more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** **Objective / Purpose:** We are seeking a highly motivated Senior Scientist to join the Potency and Functional Characterization team ... colleagues from Research, Quality Control, Process Development, Drug Product Development, and Regulatory Affairs to drive alignment on potency strategy and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures clinical studies are ... **Job Description** This role collaborates closely with the leadership of Clinical Affairs to execute clinical strategy activities and oversee aspects of clinical… more
- Pfizer (Cambridge, MA)
- …generate and perform asset-specific care gap analyses to guide Medical Affairs activities using advanced techniques such as predictive models, machine learning, ... appropriate for a variety of settings including scientific/technical, promotional, patient/consumer, regulatory , and media. + In depth understanding of the business… more
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The **Clinical Director (Principal Scientist )** has primary responsibility for the strategic planning and directing clinical research activities… more
- Cardinal Health (Mansfield, MA)
- …pharmaceutical products of Cardinal Health. Chemistry Services is a part of Quality, Regulatory & Medical Affairs (QRMA) Scientific Services. Under the umbrella ... method verification, validation and analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA). + Perform investigations of Out… more
- Pfizer (Cambridge, MA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The Senior Director (Sr. Principal Scientist ) has...including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …when applicable through close collaboration with cross-functional teams (including Medical Affairs , Clinical Development, Regulatory Affairs , Commercial, GPD ... Expertise:** + Comprehensive understanding of the pharmaceutical industry and medical affairs + Global regulatory expertise with demonstrated strong ability… more