- 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
- IQVIA (Durham, NC)
- …Good Clinical Practice (GCP), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines. This role provides advice and supports ... Operating Procedures (SOPs), International Council for Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management… more
- ICON Clinical Research (NC)
- …sciences or a related field. + Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up ... in San Diego hybrid remote. + Strong understanding of regulatory requirements and guidelines for clinical trials,...understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory … more
- Parexel (Raleigh, NC)
- …and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing ... analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need… more
- GRAIL (Durham, NC)
- …post‑analytical-strong process optimization experience, and a thorough understanding of clinical laboratory regulatory frameworks. This position is **onsite ... high-throughput laboratory automation and advanced instrumentation. + Deep understanding of clinical laboratory regulatory standards, including CLIA, CAP, NYS,… more