- NTT DATA North America (Pittsburgh, PA)
- …across the organization. + Promote compliance with healthcare and life sciences regulatory standards (eg, GxP, HIPAA, FDA ) during delivery. **Key Skills** + ... working with healthcare, pharmaceutical, or biotech clients. + Familiarity with compliance -driven delivery in regulated industries. About NTT DATA: NTT DATA is… more
- United Therapeutics (Harrisburg, PA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... partners to ensure the highest level of quality and compliance with respect to ISCR processing and reporting. The...entry processing, from start to finish (QC, medical review, regulatory submissions) + Prior clinical or post marketing experience… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... diagnosed per year, number of hepatologists). + Adheres to company and compliance guidelines, policies, and procedures. + Effective communication within FUJIFILM IVD… more
- Penn Medicine (West Chester, PA)
- …reports and those functions that he/she has primary accountability for are in compliance with all federal, state and local regulatory standards and requirements, ... for their Entity, including sourcing, advertising, interviewing, reference checking and compliance with license requirements. + Partners with managers to facilitate… more
- University of Pennsylvania (Philadelphia, PA)
- …Coordinate, organize, complete, and maintain source documents, case report forms, regulatory documents, and participant binders in accordance with ALCOA-C. Enter ... and address queries. Show vigilance in participant safety, protocol compliance and data quality. Adhere to all University of...and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. Clinical Research Coordinator B is… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... mapping for project and or post go-live support cases in compliance with the company's quality procedures. **Company Overview** At FUJIFILM Healthcare… more
- Nammo Defense Systems, Inc (Scranton, PA)
- …in complex, high-reliability environments, driving continuous improvement initiatives, ensuring regulatory compliance , and supporting defense programs from ... at developing, implementing, and managing robust quality assurance programs in compliance with ISO 9001, and MIL-STD requirements. Proven success leading… more
- Fujifilm (Harrisburg, PA)
- …testing. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... creation and maintenance of all relevant documentation required for the purposes of compliance with applicable regulations. + Assign and track work of team members.… more
- IQVIA (Wayne, PA)
- …destination platforms and provide offline & online matches. + Responsible for full compliance and adherence to FDA Pharma Guidelines (where applicable). + Work ... internal teams + Awareness of CAN-SPAM, CASL, CCPA, GDPR, and other regulatory standards related to marketing communication + Time Management skills; effectively… more
- Penn Medicine (West Chester, PA)
- …of missing charges.Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, ... etc.)Staying current with communications from the Patient Access Management Team while remaining flexible and readily adopts new processes and engages in practice operation changes.Coordinates clinical and administrative aspects of the new patient scheduling… more