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Regulatory Affairs Specialist I
Location
Tennessee
Posted
103 days ago
Salary
0
Seniority
Junior
Job Description
Regulatory Affairs Specialist I
McKesson
• 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.
Job 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.
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