Regulatory Affairs Specialist I

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🔥 0 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

🚫👨‍🎓 No degree required

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McKesson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1833

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

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

• Establish and maintain a document management system for regulatory electronic files • Maintain FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks • Ensure regulatory documentation complies with local Standard Operating Procedures (SOPs) for format and content • Maintain critical documentation ensuring compliance • Modify and/or develop informed consent forms • Update and manage protocol, investigator drug brochure, and consent form modifications or amendments in compliance with IRB policy and HIPAA • Handle time-sensitive correspondence with sponsors and other stakeholders • Organize and process documentation for IRB submission for multiple trials • Process protocol deviations meeting IRB reportable criteria • Submit urgent safety notifications to the IRB • Manage and plan regulatory affairs compliance for industry sponsors and/or sites in networks • Work closely with regulatory affairs management, the department director, and/or primary investigators • Prepare for auditing activities while meeting strict deadlines • Maintain a full study workload with minimal supervision • Perform other duties as assigned

🎯 Requirements

• High school graduation diploma required • Associate's Degree or higher is preferred • Qualified experience may be substituted for education • 1+ year work experience in clinical research, pharmaceutical, or site management organization, focused in required regulatory affairs, highly desired • Knowledge of medical terminology highly preferred • Knowledge of FDA and other regulatory processes highly preferred • Ability to maintain a full study workload with minimal supervision • Sponsorship is not available

🏖️ Benefits

• Comprehensive Total Rewards package supporting physical, mental, and financial well-being • Competitive compensation package • Annual bonus or long-term incentive opportunities may be offered • Resources and opportunities to grow and be your best • Fully remote work arrangement