Regulatory Affairs Specialist I
McKesson
full-time
Posted on:
Location Type: Remote
Location: Tennessee • United States
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Job Level
Tech Stack
About the role
- Establishes and maintains a document management system for regulatory electronic files.
- Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
- Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOPs) for format and content.
- Maintains critical documentation ensuring compliance.
- Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.
- Organizes and processes documentation for IRB submission for multiple trials.
- Processing of Protocol Deviations that meet the IRB reportable criteria.
- Submits urgent safety notifications to the IRB.
- Other duties as assigned.
Requirements
- Associate's Degree or higher is preferred, high school graduation diploma required - qualified experience may be substituted for education.
- 1+ year work experience in a clinical research, pharmaceutical, site management organization highly desired focused in required regulatory affairs.
- Knowledge of medical terminology, FDA, other regulatory processes highly preferred.
Benefits
- Comprehensive benefits to support physical, mental, and financial well-being.
- Total Rewards offerings serve the different needs of our diverse colleague population.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
document management systemregulatory documentationinformed consent formsprotocol modificationsinvestigator drug brochureIRB submissionprotocol deviationssafety notificationscompliancemedical terminology
Certifications
Associate's Degreehigh school graduation diploma