- Parexel (Raleigh, NC)
- …this is the ideal role.** We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior ... - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/ Clinical Trial Design, Clinical Strategy,… more
- Oracle (Raleigh, NC)
- …professional to drive growth across **Commercial, Real-World Evidence (RWE), Clinical , Regulatory , and Safety research services** within pharmaceutical ... partner to clients, navigating stakeholder ecosystems across Commercial, Medical, Clinical Development, Regulatory , Safety, and HEOR functions.… more
- Oracle (Raleigh, NC)
- …is building the next generation of intelligent, cloud-based healthcare platforms - combining clinical , payer, and regulatory data at scale to transform how care ... We are seeking a **Senior Principal Product Manager** who deeply understands the ** regulatory , clinical , and financial dynamics** of the healthcare ecosystem -… more
- ThermoFisher Scientific (Greenville, NC)
- …company, all while maintaining full-time benefits. **Position Summary** The Director, Clinical Regulatory Affairs serves as a senior regulatory ... leader responsible for shaping and executing the global clinical regulatory strategy across client's development portfolio. This role oversees end-to-end… more
- Sumitomo Pharma (Raleigh, NC)
- …HTA submissions. The individual will be responsible for leading development of all non- clinical and clinical regulatory strategies including management of ... to advance business goals + Provide leadership and direction to clinical regulatory . Provide coaching and development and drive a culture of excellence… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …product development and/or lifecycle management. Identifies business implications of complex regulatory and clinical issues, develops risk mitigation strategies ... Pharm. D.,M.D. or equivalent and, 8 years direct experience in Medical Research, Clinical , Regulatory Affairs or other critical areas within the pharmaceutical… more
- GRAIL (Durham, NC)
- …Qualifications:** + **Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality, or program management within the ... Affairs Certification (RAC) preferred. + Experience in pharmaceutical clinical , statistical, or regulatory settings-especially in oncology, immunology,… more
- IQVIA (Durham, NC)
- …combination of education, training and experience. * In-depth knowledge of applicable clinical research regulatory requirements (ie, Good Clinical Practice ... Job Overview Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …+ Ensure regulatory intelligence specialists have continued access to regulatory , clinical trial, and public domain information resources to identify ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...taxonomy terms relevant to Otsuka approved and investigational products, clinical , and business development programs. + Build professional network… more
- Dentsply Sirona (Charlotte, NC)
- … clinical study documentation to Independent Ethics Committees/Review Boards and Regulatory Authorities. + Registration of clinical studies in applicable ... studies for AI models. + Collaborate with R&D, Quality, Regulatory , and product marketing teams to ensure clinical... Regulatory , and product marketing teams to ensure clinical relevance and safety of AI models and assist… more