Senior Manager, Clinical Study Inspection Readiness

Role: Senior Manager, Clinical Study Inspection Readiness at Regeneron, leading GCP inspection strategies and ensuring audit preparedness across multiple clinical programs. Responsibilities: oversee end-to-end inspection processes including mock, dry run, and actual audits; coordinate with Clinical Study Teams, CROs, and Inspection Management to prepare responses and close action items; track inspection activities and manage remediation efforts; champion AI-powered tools for documentation; coach and develop team members. Requirements: BS/BA and 8+ years in clinical research or trial management; strong project management skills under inspection timelines; hands-on experience with clinical inspections preferred; experience collaborating with CROs and cross-functional teams advantageous; familiarity with AI tools a plus; proactive risk identification and effective communication essential. High-Value: global clinical trials, GCP inspection readiness, CRO partnerships, AI documentation tools, quality assurance, multi-program portfolio, onsite with up to 25% travel, based in NY or NJ.