McKesson
McKesson

McKesson je zdravstveno podjetje, ki deluje na področju distribucije farmacevtskih izdelkov, medicinskih pripomočkov in zdravstvenih storitev. Njegovo delo lekarnam, klinikam, zdravstvenim sistemom in pacientom pomaga zagotavljati dostop do ključnih terapij, hkrati pa podpira učinkovitejše delovanje zdravstva in odporen odziv na pomanjkanje zdravil.

Podjetje razvija tudi programsko opremo za upravljanje lekarn, svetovalne storitve in tehnološke rešitve za specializirane prakse. McKesson sodeluje z biofarmacevtskimi organizacijami ter podpira onkološke in biofarmacevtske prakse s storitvami, osredotočenimi na dostop do zdravil, upoštevanje zdravljenja, komercializacijo, podatkovno podprte vpoglede in dokaze iz resničnega sveta.

Regulatory Affairs Coordinator – Tennessee Remote

Coordinate FDA and Good Clinical Practice documentation for SCRI’s community oncology trials. Support clinical sites and sponsors with regulatory records, signatures, audits, and compliance.

Opis

  • Coordinate regulatory compliance for industry sponsors and network sites.
  • Partner with regulatory leaders, department directors, and principal investigators to support compliance.
  • Prepare for audits and meet strict deadlines.
  • Process regulatory document signature requests using an electronic signature platform.
  • Track regulatory documents awaiting site signatures.
  • Support Clinical Operations sites and internal managers with site-level regulatory needs.
  • Set up and maintain regulatory document systems for paper and electronic records.
  • Maintain FDA- and GCP-required records for sites, studies, sponsors, and networks.
  • Check regulatory documents against local SOP requirements for format and content.
  • Keep physician credentials and other key records current.
  • Assess site requests for regulatory support and direct each issue to the appropriate resolution process.

Zahteve

  • Associate degree required; bachelor’s degree preferred.
  • Regulatory experience preferred.
  • Customer service experience preferred.
  • Knowledge of FDA and Good Clinical Practice (GCP) regulatory documentation.
  • Ability to ensure regulatory documents meet local standard operating procedure (SOP) requirements.
  • Ability to meet strict deadlines and prepare for audits.
  • Ability to keep physician credentials and other critical compliance records current.

Ugodnosti

  • Benefits package supporting physical, mental, and financial well-being.
  • Competitive compensation package.
  • Annual bonus or long-term incentives may be offered.
  • Equity may be included in compensation.
  • Total Rewards package.

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