- 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
- ThermoFisher Scientific (Wilmington, NC)
- …skills * Excellent coaching and mentoring skills * Knowledge and understanding of clinical development regulatory guidelines and Directives * Ability to work ... (Mon-Fri) **Environmental Conditions** Office **Job Description** **Join Us as Director Clinical Operations - Make an Impact at the Forefront of Innovation**… more
- IQVIA (Durham, NC)
- …and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements. You should have: + A Bachelor's degree ... - escalating quality issues as appropriate + Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query… more
- Deloitte (Raleigh, NC)
- Healthcare Clinical Documentation Specialist - Senior Consultant Our Deloitte Regulatory , Risk & Forensic team helps client leaders translate multifaceted risk ... include: + Operational Improvement: For business process that include significant clinical documentation and regulatory requirements, you will improve efficiency… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- … clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is ... and internal processes. + Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and… more