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McKesson
McKesson
H1B Visa SponsorConsultingHealthcareLogistics

McKesson is a healthcare company operating across pharmaceutical distribution, medical supplies, and healthcare services. Its work helps pharmacies, clinics, health systems, and patients access essential therapies while supporting more efficient healthcare operations and a resilient response to drug shortages.

The company also develops pharmacy management software, consulting, and technology solutions for specialty practices. McKesson works with biopharma organizations and supports oncology and biopharma practices through services focused on medication access, adherence, commercialization, data-driven insights, and real-world evidence.

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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.

USUnited StatesTNTennesseeRemoteFull-timeMiddleSeniorEnglish RequiredCompliance
Google Cloud Platform

Description

  • 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.

Requirements

  • 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.

Benefits

  • 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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