- Chiesi (Cary, NC)
- …newly created position will initially focus on pre-launch preparation in anticipation of FDA approval of our global market leading product, Trimbow(R). We want to ... achievement of goals and an eye towards innovation. + Ensure compliance with regulatory , legal, and corporate requirements both separately and for asthma and copd… more
- Chiesi (Cary, NC)
- …newly created position will initially focus on pre-launch preparation in anticipation of FDA approval of our global market leading product, Trimbow(R). We want to ... meetings, events, and other activities as needed + Ensure compliance with regulatory , legal, and corporate requirements both separately and for the sickle cell… more
- ThermoFisher Scientific (Wilmington, NC)
- …and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) ... attention to detail + In-depth understanding of relevant regulations eg ICH/GCP, FDA guidelines, etc. + Strong computer skills to effectively use automated systems… more
- Teleflex (Morrisville, NC)
- …and support to clinical end-users, clinical sales specialists, sales team, Regulatory , Engineering, marketing, and other corporate departments on safe and effective ... requirements. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations,… more
- IQVIA (Durham, NC)
- …+ Ensures study level ADaM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and ... consistency in metadata use and development. + Actively monitors for new regulatory requirements related to data standards and/or data submissions; Communicates and… 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 ... signal detection, data analysis, risk management, aggregate reporting, and regulatory compliance activities and should have strong critical thinking, medical… more
- Veterans Affairs, Veterans Health Administration (Wilmington, NC)
- …and documentation in compliance with required rules and regulations of regulatory and accrediting agencies and organizations. -Assists the Supervisors in ensuring ... Pathologists (CAP), Joint Commission and the Food and Drug Administration ( FDA ). -Reviews all new procedures, initially and annually thereafter, documenting… more
- ThermoFisher Scientific (Wilmington, NC)
- …and ensure that essential document quality meets the expectation of Regulatory Compliance Review. Ensure timely regulatory submissions (if appropriate) ... Clinical monitoring or clinical site support; and Regulations such as ICH/GCP, FDA guidelines, and local regulations. Four (4) years of experience with: Working… more
- J&J Family of Companies (Wilson, NC)
- …and guidelines including FDA , EPA, OSHA, DEA and TSA. + Ensures regulatory and job training remains current by promptly completing required training + Comply ... that automated systems are fit for intended use and follow applicable regulatory requirements (eg cG(a)MP) and company manufacturing standards throughout the entire… more
- UNC Health Care (Raleigh, NC)
- …study requirements, federal regulations, etc. 8. Participate in sponsor audits and/or regulatory inspections of records and documents (eg FDA , CLGB/NSABP) ... by protocol. 6. Follows established guidelines in the collection of data. 7. Ensures regulatory compliance for each study by following IRB policies and procedures,… more