- Astellas Pharma (Cambridge, MA)
- …enterprise objectives. -Play a strategic lead role, in collaboration with Research, Regulatory Affairs and Early Development and Translational Sciences, to ... across Oncology and Biopharma/Cell&Gene and with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance/Medical Safety… 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… more
- Sanofi Group (Cambridge, MA)
- …regulatory , statistics, and PM) + The CRD will lead the preparation of clinical documents/reports for regulatory submission and will attend meetings with ... **Job Title:** Clinical Research Director - RBD **Location:** Cambridge, MA...will work in conjunction with the Commercial and Medical Affairs to support the creation of the product value… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions + Coordinate interdepartmental ... principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, ... of my knowledge. **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs . + Advanced knowledge of regulatory guidance ... simulation approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with… more
- Sanofi Group (Cambridge, MA)
- …patient advocacy associations, clinical development, Global Medical Leadership, Regulatory , Medical Affairs , Product Communications, and lead agency ... KOL- and customer-validated Rilzabrutinib disease and science story in partnership with Clinical Development and Global Medical Affairs . + Provide oversight and… more
- AbbVie (Boston, MA)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other ... to augment expertise in the therapeutic area. + Responsible for understanding the regulatory requirements related to the clinical studies and global drug… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …advanced development team and with cross-functional team members in scientific and clinical affairs , product development, regulatory , quality, and ... is highly creative and innovative in identifying solutions to complex clinical challenges. This individual is also responsible for coordinating and performing… more
- Commonwealth Care Alliance (Boston, MA)
- …+ Interdepartmental stakeholders include but are not limited to: quality; regulatory affairs /compliance; clinical , operations, pharmacy, dental, reporting, ... and meeting all strict deadlines. + When necessary collaborate with care teams, clinical staff, family members, and other involved in providing care for our members.… more
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