- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... inception (Phase 1-3) to successful product approval by the FDA and other regulatory agencies. + Design and review...+ Attention to detail and a commitment to high quality and on-time deliverables are key success factors +… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Demonstrated knowledge of regulatory/compliance requirements, including anti-kickback laws, FDA promotional regulations, Sunshine Act; and demonstrated knowledge of… more
- Sumitomo Pharma (Raleigh, NC)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop and… more
- Actalent (Cary, NC)
- …The successful candidate will contribute to the mission of delivering high- quality care to patients. Responsibilities + Counsel and educate existing patients ... on REMS FDA -mandated medications, including reading a list of statements to...events (AEs) and product complaints (PCs) to the manufacturer, FDA , and/or other governing authorities. + Provide specialty drug… more
- Owens & Minor (Morrisville, NC)
- …a global company **ABOUT THE COMPANY** _Apria Healthcare's mission is to improve the quality of life for our patients at home. We are looking for empathetic, ... is performed on a timely basis according to DOT, FDA and Joint Commission. + Responds to emergency delivery...+ Must meet job-related requirements to comply with DOT, FDA and Joint Commissions regulations. **SKILLS, KNOWLEDGE AND ABILITIES**… more
- Chiesi (Cary, NC)
- …than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the ... and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing...drug promotion/advertising and US labeling, and experience interacting with FDA OPDP + Experience with Veeva Vault PromoMats and… more
- IQVIA (Durham, NC)
- …make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. Experience ... compliance with applicable regulatory, medical, and ethics guidelines. + Ensure high- quality , data-driven deliverables that meet the highest standards of medical,… more
- GRAIL (Durham, NC)
- …play a key leadership role in shaping and strengthening Grail's Clinical Quality Management System (CQMS) and advancing clinical compliance oversight across clinical ... and CDx regulatory risks, lead inspection readiness, and continuously improve quality standards utilizing insights from inspections, audits, and evolving regulatory… more
- ThermoFisher Scientific (Greenville, NC)
- …We are seeking an experienced and meticulous QA Engineer III to join our Quality Assurance team as a Quality Validation Specialist. The ideal candidate will ... have a strong background in quality validation processes, excellent analytical skills, and a dedication...Familiarity with relevant industry standards and regulations (eg, ISO, FDA , GMP) is highly desirable. + **Certifications** : Relevant… more
- ThermoFisher Scientific (Wilmington, NC)
- …in partnership with the Project Manager to ensure the necessary training, tracking and quality systems are in place for the clinical management team and be primarily ... Works to ensure that all clinical deliverables meet the customer's time/ quality /cost expectations. Maintains profitability by ensuring clinical activity is conducted… more