- 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
- Oracle (Raleigh, NC)
- …product management team focused on medical device-aligned products. This team bridges clinical practice, product strategy, and regulatory engineering to ensure ... across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight… more
- Oracle (Raleigh, NC)
- …product management team focused on medical device-aligned products. This team bridges clinical practice, product strategy, and regulatory engineering to ensure ... across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight… more
- GRAIL (Durham, NC)
- …data lifecycle, from sample ingestion through analysis, ensuring every step meets rigorous regulatory and clinical standards. We are seeking a Staff Software ... and database management, with demonstrated success delivering data solutions for clinical or regulatory use cases. + Expertise in SQL and proficiency in Go… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …BU Lead and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory , Commercial) to ensure global and US alignment ... regulatory requirements. + Collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory , Legal, and Commercial teams to ensure… more