- 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
- Edwards Lifesciences (Raleigh, NC)
- …impact:** + Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (eg, clinical study reports, clinical ... teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle + Manage activities with… more
- Merck (Raleigh, NC)
- …readiness as well as preparing for, management and follow up of regulatory inspections. **Operational Quality Management:** + The Clinical Quality Operations ... current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those… more
- IQVIA (Durham, NC)
- …of development from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the ... for various clients. + Provide strategic and therapeutic area guidance for clinical development plans in compliance with applicable regulatory , medical, and… more
- ThermoFisher Scientific (Greenville, NC)
- …of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at ... are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client… more
- Norstella (Raleigh, NC)
- …in scoping discussions and helping design custom RWD solutions that address key clinical , regulatory , and business questions. + And other duties as assigned ... electronic health records (EHRs)** . You will be responsible for translating clinical and medical data requests into structured queries, ensuring that extracted data… more
- IQVIA (Durham, NC)
- …clinical trial delivery + Robust and current knowledge of scientific, clinical , regulatory , commercial and competitive landscape in applicable therapeutic ... Therapeutic Strategy Lead who is experienced in obesity global clinical trial development and can support customer engagement and...role, it is important to understand Endocrinology and Obesity clinical trial operations from Phase 1 to Phase 3… more