- Takeda Pharmaceuticals (Cambridge, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs . + Advanced knowledge of regulatory ... Pharmacology (QCP) Lead in our Cambridge, MA office. Our Data and Quantitative Sciences group (DQS) is made up...(eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with… more
- Sumitomo Pharma (Boston, MA)
- …including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is ... and ensure patient safety. + Assist in signal detection activities including data assembly, signal validation, and signal evaluation. + Perform literature monitoring… more
- Genentech (Boston, MA)
- …best practices + Partner closely with senior leadership across PD-DSA, clinical development, regulatory affairs , and data science teams to shape the ... between the Biostatistics function and key stakeholders across Clinical, Regulatory , and Data Science teams to drive...TA and TA-enabling strategy. Ability to consult and understand medical issues + In-depth knowledge of GCP, international and… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …team and with cross-functional team members in scientific and clinical affairs , product development, regulatory , quality, and manufacturing. Essential Functions: ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more
- Baystate Health (Springfield, MA)
- …and Regulatory Compliance** + Collaborates with the VP, Safety and Regulatory Affairs , to ensure hospital compliance with The Joint Commission, CMS ... performance, measurement and improvement throughout Baystate Health, including our academic medical center and community hospitals. Reporting directly to the **Chief… more
- ConvaTec (Lexington, MA)
- …project work + **Scientific & Technical Labs** to execute testing, as required. + ** Regulatory Affairs ** to collaborate on requirements as well as gain early ... with internal teams, including Applied Research, New Product Development, Marketing, Medical and Clinical Affairs , Market Access, and External Innovation,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions + Coordinate interdepartmental ... deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device Clinical Strategy & Risk Management:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …of experience in GCP Quality/Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, ... and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's… more
- Integra LifeSciences (Braintree, MA)
- …communicating testing activities. The role works with Product Development, Project Management, Regulatory , Marketing and Medical Affairs . **ESSENTIAL DUTIES ... in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs . Support Design Reviews, Technical Reviews, and Gate… more
- Integra LifeSciences (Braintree, MA)
- …testing activities. The role works closely with Product Development, Project Management, Regulatory , Marketing and Medical Affairs . **ESSENTIAL DUTIES AND ... in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs . Support Design Reviews, Technical Reviews, and Gate… more