- Leica Biosystems (Boston, MA)
- …and PMA in USA) and will mentor the organisation in these key activities. The Senior Principal Regulatory Affairs will collaborate cross-functionally and ... an impact.Learn about the Danaher Business System which makes everything possible.The Senior Principal , Regulatory Affairs is responsible for … more
- Merck & Co. (Boston, MA)
- Job Description Senior Principal Scientist Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for ... the Immunology Therapeutic Area Lead in Translational Medicine.Primary responsibilities for the Senior Principal Scientist include the following:Key member of an… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has...including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director… more
- Danaher Corporation (Boston, MA)
- …and PMA in USA) and will mentor the organisation in these key activities. The Senior Principal Regulatory Affairs will collaborate cross-functionally and ... Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal , Regulatory Affairs … more
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... and drive the timely delivery of high-quality pharmaceutical products. ** PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy...of experience in regulatory affairs , focusing on regulatory … more
- Merck (Boston, MA)
- **Job Description** ** Senior Principal Scientist Translational Medicine, Immunology** Translational Medicine in our Research & Development Division is ... Immunology Therapeutic Area Lead in Translational Medicine. **Primary responsibilities for the Senior Principal Scientist include the following:** + Key member… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The Senior Director (Sr. Principal Scientist) has...including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior … more
- Edwards Lifesciences (Boston, MA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and … more
- HNTB (Boston, MA)
- …protocols to ensure compliance with design criteria, scientific specifications, and regulatory approvals/permits. + Serves as senior reviewer of technical ... of proposed projects. + Serves as task lead or principal author in the preparation of reports, on environmental...state, and federal environmental permits as well as other regulatory compliance laws and regulations. + Organizes and participates… more
- Bausch + Lomb (Boston, MA)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, ... are being met and provide the operations director and/or senior management with timely updates on progress and changes...timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house… more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... is true to the best of my knowledge. **Job Description** **Objective:** ** Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the… more
- Fresenius Medical Center (Waltham, MA)
- …remediation measures. + Works in conjunction with the law department, regulatory and government affairs to better understand operational requirements ... Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements. Responsible for the development, implementation… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …in clinical research field is preferred. + Must have strong knowledge of regulatory affairs , research ethics and the responsible conduct of research. Dana-Farber ... startup activities, providing training to participating site research staff, regulatory submissions, safety event tracking and reporting, deviation/violation tracking… more
