Compliance Program Intern
Exact Sciences
Regulatory Affairs Coordinator
McKesson
full-time
Posted on:
Location Type: Remote
Location: Remote • Tennessee • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks
- Working closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance
- Preparing for auditing activities while meeting strict deadlines
- Processing regulatory document signature request through an electronic signature platform
- Tracking documents pending site regulatory signatures
- Providing site level regulatory support to the Clinical Operations’ sites and internal department managers in relation to the status of start-up and ongoing regulatory maintenance
- Establishing and maintaining a document management system for regulatory paper and electronic files
- Maintaining FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks
- Ensuring all regulatory documentation is compliant with local Standard Operating Procedures for format and content
- Maintaining updated physician credentials for network participants and other critical documentation ensuring compliance
- Triage site requests for regulatory support and identifies correct pathway for issue resolution
Requirements
- An Associate Degree, preferably a Bachelor’s Degree
- Regulatory experience is preferred
- Customer service experience is preferred
Benefits
- Comprehensive benefits to support physical, mental, and financial well-being
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairs compliancedocument management systemregulatory documentationauditing activitieselectronic signature platformGCPFDA complianceregulatory supportregulatory maintenanceStandard Operating Procedures
Soft skills
planningcommunicationcustomer serviceissue resolutionorganizational skillstime managementcollaborationattention to detailproblem-solvinginterpersonal skills
Certifications
Associate DegreeBachelor’s Degree
