- Takeda Pharmaceuticals (Cambridge, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director , Commercial Engagements & P2P Strategy, offers a unique opportunity ... external partners in a rapidly evolving market You will report to the Director , Head of HCP Engagements **How you will contribute:** + Champion Medical Communication… more
- Blue Cross Blue Shield of Massachusetts (Boston, MA)
- …help us transform healthcare? Bring your true colors to blue. What we need The Associate Director of Clinical Data Management will be a key leader in executing ... leadership role that requires strong technical expertise, excellent communication and project management skills, and the ability to work collaboratively with… more
- J&J Family of Companies (Woburn, MA)
- …at https://www.jnj.com/medtech **We are searching for the best talent for** **an Associate Director of Sensor Operations** **.** **Purpose:** The Sensor ... CAPA muscle and making ETQ our standard work. + Project a clear vision for the future of site...related technology + Experience managing compliance associated with quality, regulatory , and safety policies + Experience transitioning product and… more
- RTX Corporation (Boston, MA)
- …our enhanced focus on multi-mode value delivery, including traditional project management, Agile product delivery, and operational/program financial analysis ... the function and DT. + Oversee all the normal PM fundamentals: project schedule, key decisions, resources, financials, requirements, issues, risks, dependencies. +… more
- AbbVie (Cambridge, MA)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. ... Oversees project -related education of investigators, study site personnel, and AbbVie...scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. +… more
- Bristol Myers Squibb (Cambridge, MA)
- …activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives ... Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and regulatory interactions as needed **Skills/Knowledge… more
- Takeda Pharmaceuticals (Boston, MA)
- …related to the drug development process and into preparation for key regulatory meetings as appropriate. + Leads Clinical Operations aspects of inspection readiness ... activities and acts as subject matter expert during regulatory inspections. + Lead or participate in cross-functional strategic initiatives and process improvement.… more
- Takeda Pharmaceuticals (Boston, MA)
- …clinical + Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors ... industry standards applicable to the design, analysis of clinical trials and regulatory submissions. + Strong statistical programming skills + Excellent oral and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …the timely execution of statistical and research methodological components to meet project objectives and has a thorough understanding of current requirements for ... statistical expertise and delivery of analyses. + Actively participate in project /study team meetings. Develop statistical sections of protocols; participate in… more
- State of Massachusetts (Boston, MA)
- …against licensees who engage in professional misconduct when necessary. The Executive Director ("ED") for MSAC reports to the Associate Deputy Commissioner ... Provide written and oral advice to the Agency on regulatory matters related to MSAC. * Establish and maintain...records unit with filling these requests. * Assist the Director of External Affairs and the OCA Legislative Liaison… more