- 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)
- …510k and PMA in USA) and will mentor the organization in these key activities. The Senior Principal Regulatory Affairs will work with Biopharma partners ... Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal , Regulatory Affairs … more
- Bausch + Lomb (Boston, MA)
- …Bachelor degree or equivalent, Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment + Ability to ... + Strong business acumen and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative ideas to promote a successful… 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...pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior … more
- Dana-Farber Cancer Institute (Brookline, MA)
- …primary reporting contact for the Institutional IND portfolio managed by the CTO Regulatory Affairs Core. The Institutional IND RC centrally prepares, submits, ... Coordinators (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and / or directly...As necessary, the Institutional IND RC assists the CTO Regulatory Affairs Core with other required hard… 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
- 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
- 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
