Regeneron
SeniorManagerClinicalStudyInspectionReadiness
“Senior Manager Clinical Study Inspection Readiness at Regeneron. Skills: Inspection readiness, Clinical study management, Regulatory compliance. Lead GCP inspection readiness programs. Manage inspection readiness strategy”
Industry & Context.
Root cause analysis; Remediation plans
Up to 25% travel
What They're Looking For.
Must Have
8+ years relevant clinical experience, BSA Degree
Nice to Have
Clinical Inspection experience
What You'll Do.
Lead GCP inspection readiness programs
Manage inspection readiness strategy
Provide inspection readiness leadership
Serve as CTM inspection readiness point of contact
Act as project manager during inspection process
Assist CTM team with follow up requests
Support CTM in providing responses to Q&A
Support ongoing CTM activities related to TMF health
Provide guidance on compliance and regulations
Ensure CTM staff follow SOPs
Track inspection readiness meetings
Manage CTM inspection action items
Support TMF documentation production
Obtain essential and regulatory documents
Track CTM action items assigned following inspections
Lead internal process improvement projects
Utilize AI-powered applications to draft documents
Establish goals for direct reports
Review performance of direct reports
Manage training for direct reports
How You'll Work.
Team & Collaboration
Partner with POLs; Partner with CSLs; Work with CST; Work with functional areas; Work with CRO partners; Work with Vendor team
Communication Scope
Executive summaries; Response documents; Executive communication
Process & Methodology
Project management
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