- 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
- IQVIA (Durham, NC)
- …and close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference ... Req * Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (ie, Good Clinical Practice (GCP) and International… more
- IQVIA (Durham, NC)
- …clinical project delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical ... management practices and terminology. + Requires good knowledge of applicable clinical research regulatory requirements ie, Good Clinical Practice (GCP) and… more
- BAYADA Home Health Care (Charlotte, NC)
- …home care services. This role ensures that all care provided meets clinical standards, regulatory requirements, and organizational goals. The Clinical ... home visits to ensure adherence to care plans, nursing standards, and regulatory guidelines + Monitor clinical documentation for accuracy, timeliness, and… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …**Primary Responsibilities:** + **Participate in the development and review of the Clinical SOPs, Regulatory documents and Study Plans** + Participate in ... in the study plans reviews + Participate in the review of Regulatory Documents ( Clinical Study Protocol, Investigators Brochure, Informed Consent Form,… more