- 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
- Cytel (Raleigh, NC)
- …longitudinal analysis. + Review and contribute to study reports and quantitative clinical pharmacology l sections of regulatory submission dossiers, lead ... electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities. + Develop strong collaboration… more
- Granville Medical Center (Oxford, NC)
- …Responsibilities: + Clinical Compliance: + Monitor and ensure adherence to clinical standards and regulatory requirements across all outpatient practices. + ... is highly desirable. BSN Preferred. + Skills: + Strong knowledge of clinical standards and regulatory requirements. + Excellent communication, leadership, and… more
- Granville Health System (Oxford, NC)
- …Key Responsibilities: Clinical Compliance: Monitor and ensure adherence to clinical standards and regulatory requirements across all outpatient practices. ... roles is highly desirable. BSN Preferred. Skills: Strong knowledge of clinical standards and regulatory requirements. Excellent communication, leadership, and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is ... report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and… more
- ThermoFisher Scientific (Wilmington, NC)
- …management strategies + Closely collaborate with stakeholders internally (eg Regulatory Affairs, clinical development, medical affairs) and externally ... narratives) for assigned product(s) + Prepare and/or review safety sections of clinical / regulatory documents (including study protocols, IBs, Clinical Study… more
- ThermoFisher Scientific (Wilmington, NC)
- …of issues in consultation with the Global Medical Indication Lead + Interpret the clinical trial data for regulatory documents (eg CSR, INDs, Annual Reports, ... step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel… more