- Regeneron Pharmaceuticals (Cambridge, MA)
- …a critical role overseeing the strategy, preparation, and submission of high‑ quality INDs, CTAs, and original marketing applications (BLAs/MAAs) and interactions ... discussions with external and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic company guidance on FDA… more
- East Boston Neighborhood Health Center (East Boston, MA)
- …* developing and updating departmental clinical policies and procedures * overseeing clinical quality management of the department * assisting the department in ... Summary/Responsibilities: In collaboration with Adult Medicine leadership team, the Medical Director is responsible for * collaborating closely with Adult Medicine… more
- Takeda Pharmaceuticals (Boston, MA)
- …team. + Lead and embed the process for collating, trending and interpretation of quality data for actionable insights including the identification of systematic ... experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience… more
- AbbVie (Worcester, MA)
- …pharmaceutical/biotechnology industry. + Proven experience in enabling new digital or data management capabilities beyond incremental improvements or routine ... the needs of scientists and work to develop a data systems architecture foundational for knowledge management ,...other divisions within PDS&T, Dev Sci, Manufacturing, and the Quality organizations. The leader will prioritize use cases and… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Neurology and Immunology HEVA Business Partner **Location:** Cambridge, MA **About the Job** Sanofi's specialty care business unit focuses ... including presentation skills + Significant experience making presentations to senior management is preferred + Publication in peer-reviewed journals + Strong… more
- Bristol Myers Squibb (Cambridge, MA)
- …to late-stage clinical development, their approval and life cycle management . Early-stage translational development activities enable rational determination of ... of BMS's therapies post-clinical proof-of-concept, including registrations and life-cycle management . Translational disease strategies in Alzheimer's /Neurological Diseases are… more
- Takeda Pharmaceuticals (Boston, MA)
- … and risk management standards. + Work closely with architecture, engineering, quality , and data teams to ensure scalable and interoperable solutions across ... Regulatory Affairs Technologies (RIM systems, publishing tools, global submission management , labeling platforms, IDMP readiness). Pharmacovigilance Technologies (safety databases,… more
- Highmark Health (Boston, MA)
- …Highmark Health Solutions, Health Plan Operations. **ESSENTIAL RESPONSIBILITIES** + Perform management responsibilities to include, but are not limited to: involved ... termination decisions, coaching and development, rewards and recognition, performance management and staff productivity. Plan, organize, staff, direct and control… more
- Takeda Pharmaceuticals (Boston, MA)
- …ensure proper resourcing, planning and on-time execution from a project management and submission support perspective. + Provide strategic leadership for end-to-end ... vendor to plan, track and manage submissions and information management for all PDT products globally. + Works with...Ensures a system within PDT RA for driving regulatory quality compliance and efficiency across the organization. + Accountable… more
- Takeda Pharmaceuticals (Boston, MA)
- …protocols, statistical analysis plans (SAPs), and reports. + Familiarity with software for management and analysis of data . + Follows best practices for ... for quality and disclosure + Accountable for project(s) contract/budget management . + Reviews and develops scientific reports reflecting ongoing or completed… more