- 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
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Outlook, Excel, and Word. In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; ie Good Clinical Practice ( GCP ... - $84,000 Position Summary/Description: This position will serve as a Senior Clinical Research Coordinator within the Department of Surgery, Division of Burn. The… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- … Clinical pharmacology, in the broadest sense, encompasses drug discovery, clinical development, regulatory issues, therapeutic use and individualization of ... Vacancy ID: PDS004510 Position Summary/Description: The UNC -Duke Collaborative Clinical Pharmacology T32 Postdoctoral Training Program is a collaboration between… more
- Sumitomo Pharma (Raleigh, NC)
- …partners/sponsors, KOL's, and patient advocacy groups. + Contribute to company's planned regulatory filings including authoring clinical sections for INDs, NDAs, ... clinical research program with minimal direction + Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing … more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …**Knowledge, Skills, and Abilities:** Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. ... medicines, solutions and services in more than 110 countries and regions. The Clinical Research Associate assists in the management of the clinical monitoring… more
- ThermoFisher Scientific (Wilmington, NC)
- …programs and operational practices. + **Stakeholder Alignment:** Interact with Regulatory Affairs, Clinical , Quality, Pharmacovigilance and Legal teams ... step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel… more
- ICON Clinical Research (NC)
- …and we welcome you to join us on our mission to shape the future of clinical development. Sr Manager, Regulatory Affairs - IVD Location: US Remote, Portland, OR ... experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical … more