- Takeda Pharmaceuticals (Lexington, MA)
- …true to the best of my knowledge. **Job Description** **About the Role:** The Associate Director of Device Clinical Development (DCD) in the Drug Product and ... Clinical Strategy & Risk Management:** + Develop Device Clinical Development Strategy for Combination Products and Medical Devices + Develop… more
- Wolters Kluwer (Waltham, MA)
- …a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important ... regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards.… more
- Sanofi Group (Cambridge, MA)
- …innovative projects. The incumbent will work closely with key stakeholders including clinical , medical affairs, Industrial Affairs ( Device Development, ... **Job Title:** GRA Device Lead ( Director ) **Location** : Morristown,... team is a globally diverse team supporting the medical device , combination product, digital health and… more
- Philips (Cambridge, MA)
- The Director Medical Writing & Clinical...**analyzes** clinical and safety data to support medical device performance in alignment with EU ... standards (MEDDEV 2.7.1 Rev. 4, EU Medical Device Regulation). + **Author** and **maintain** clinical ...of 10+ years combined experience working within FDA regulated medical device and clinical environments,… more
- Bausch + Lomb (Boston, MA)
- …functional areas to provide input on study-related documents and issues (DMP, SAP, drug/ device supplies, CSR, etc.). + Provides clinical operations input in the ... global team members, other B&L departments (eg, R&D/Project Management, Clinical / Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as Director , Quantitative Clinical Pharmacology (QCP) Lead in our Cambridge, MA office. Our ... interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/ Device , and… more
- ZOLL Medical Corporation (Boston, MA)
- …MBA, MD, PhD, or equivalent) is preferred. Experience : + 5+ years of clinical or medical device /pharmaceutical industry experience. Required. + 7+ years ... that makes ZOLL the ideal place to build your career. Job Overview: ZOLL Medical Corporation is seeking a Professional Relations Director to lead and manage… more
- Hologic (Marlborough, MA)
- …practices, particularly in Breast/GYN or General Surgery. + Strong knowledge of medical device regulations, compliance standards, and risk management processes. ... Sr Director , Medical Safety Officer San Diego,...action processes. + Analytical and critical thinking skills for clinical study design, risk assessments, and safety evaluations. **Behaviors**… more
- United Therapeutics (Boston, MA)
- …difference. The Regional Field Director , RNS Program Management serves as a director of all clinical field activities on the commercial non-promotional team. ... PAH disease state, disease progression, risk stratification, therapies, and clinical considerations. You are ultimately looking to work for...In addition, the Regional Field Director , RNS Program Management will: + Serve as the… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, ... the Company-wide patient safety expert for assigned pharmaceutical / biological / drug- device combined products, accountable for the safety strategy and major safety… more