- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** Job Title: Microbiological/Environmental Monitoring Manager and Investigator Location: Lexington, MA **About the role:** Primary duties ... of this position include serving as a lead for various technical aspects of the QC and...contamination investigation regarding impact to lot release for commercial manufacturing . Includes being a subject matter expert for and… more
- GE HealthCare (Boston, MA)
- …and Global Compliance support to R&D & GCP activities but also to the GMP manufacturing sites, GDP, PV, and GLP related functions. This role reports directly to the ... Leader Pharmaceutical Diagnostics. The role will oversee, coordinate and lead audits on behalf of PDx QRA with a...R&D functions including to but not limited to CRO's, Investigator sites, Centralised Labs and specialist Non Clinical Labs.… more
- Merck (Boston, MA)
- …preparing clinical regulatory documents (eg, protocols, clinical study reports, investigator 's brochures, clinical sections of submissions) per company and ... a subset of clinical regulatory documents (eg, clinical study reports, investigator 's brochures, clinical sections of submissions) per regulatory requirements and… more
- Sanofi Group (Boston, MA)
- …of science to improve people's lives. We believe our cutting-edge science and manufacturing , fueled by data and digital technologies, have the potential to transform ... and identifying opportunities for further data collection clinical or investigator -led.** + Monitors disease epidemiology and provides support, including protocol… more
- Merck (Boston, MA)
- …and goals for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies and serve as a role model for other ... Enhances the comprehension of the scientific foundations and goals of investigator -sponsored research. + Identifies barriers to patient enrollment and retention… more
- Merck (Boston, MA)
- …and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products ... + Reports to Executive Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy to optimize label and obtain… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …of our new Regeneron Cell Medicines (RCM) group. You will independently lead our clinical study, including planning, maintaining timelines and budgets, vendor ... as well as participating in the development and amendments of protocols, investigator brochures, informed consents, etc. + Performing research site activities, such… more