Regulatory Affairs Specialist

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🔥 4 hours ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

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McKesson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1833

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare Insurance • Pharmaceuticals • Biotechnology

McKesson is a diversified healthcare leader specializing in pharmaceutical distribution, medical supplies, and healthcare services. Their solutions facilitate patients' access to life-changing therapies, support efficient operations for pharmacies, health systems, and clinics, and address critical issues such as drug shortages through a resilient supply chain. McKesson provides comprehensive services such as pharmacy management software, consulting, and technology solutions for specialty practices, focusing on improving health outcomes and advancing the pharmaceutical industry. They work closely with biopharma companies to enhance medication access, adherence, and commercialization while supporting oncology and biopharma practices through data-driven insights and real-world evidence.

📋 Description

• Managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks • Working closely with regulatory affairs management, department director and/or primary investigators to ensure compliance • Preparing for auditing activities while meeting strict deadlines • Maintaining a full study workload with minimal supervision • Establishing and maintaining a document management system for regulatory 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 (SOPs) for format and content • Modifying and/or developing informed consent forms and updating and managing protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA • Organizing and processing documentation for IRB submission for multiple trials • Processing of Protocol Deviations that meet the IRB reportable criteria • Submitting 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