- Cardinal Health (Raleigh, NC)
- …a driven and skilled attorney with expertise in healthcare regulatory compliance , including third party billing and reimbursement. The Assistant General Counsel ... colleagues across the AHS order entry and revenue cycle management team, Compliance , the Enterprise Privacy Office, and other internal teams to identify and… more
- Cardinal Health (Raleigh, NC)
- …We also provide customers the support they need in regulatory compliance , reimbursement, continuing education, information management and other crucial areas, so ... investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, including… more
- Fujifilm (Raleigh, NC)
- …diagnosed per year, number of hepatologists). + Adheres to company and compliance guidelines, policies, and procedures. + Effective communication within FUJIFILM IVD ... organization of sales, quality and compliance issues. + Utilization of the IVD reporting systems...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Fujifilm (Raleigh, NC)
- …process changes to improve efficiency and customer satisfaction. + Ensure compliance with all applicable requirements of the company's quality management system. ... HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the position… more
- 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 ... Maintain documentation for all automation solutions, ensuring clarity, traceability, and compliance with internal standards + Lead the end-to-end design and… more
- Lilly (Concord, NC)
- …for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. + Collaborate ... Reviews and updates training plans as needed to maintain compliance and excellence. + Develop area documentation (procedures, work...2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + STEM… more
- Stantec (Raleigh, NC)
- …related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in ... and automated systems which require qualification and validation for compliance . The commissioning and validation of equipment, facilities, utility systems… more
- UNC Health Care (Raleigh, NC)
- …Provides education and communication on clinical research activities and ensures compliance for all studies by following protocols and procedures. Responsibilities: ... Follows established guidelines in the collection of data. 7. Ensures regulatory compliance for each study by following IRB policies and procedures, study… more
- Grifols Shared Services North America, Inc (Jacksonville, NC)
- …teams of needed updates/changes **Additional responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, & ... abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding...to evaluate complex issues and meet deadlines to ensure compliance , as well as business timelines to accomplish company… more
- Sumitomo Pharma (Raleigh, NC)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... (written, verbal, electronic, etc.) that an employee encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable… more