Manager, REMS
AstraZeneca · Wilmington, DE
SafetyFull-timeCompany career page
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Role summary
AstraZeneca seeks a Manager, REMS to lead operational execution of Risk Evaluation and Mitigation Strategy programs ensuring FDA compliance and patient safety. The role requires end-to-end program oversight, vendor management, data reconciliation, and regulatory submissions to maintain uninterrupted access to medicines.
What they're looking for
- Bachelor's degree in life science, health-related, or business discipline
- 5+ years REMS operations, pharmacovigilance, regulatory operations, or compliance experience in biopharmaceutical industry
- Strong data reconciliation, KPI dashboard, and Excel analytics skills
- Experience managing vendors, contracts, and budgets in regulated environments
- Demonstrated knowledge of FDA regulatory requirements and industry best practices
- Excellent written and verbal communication with strong attention to detail
What you'll be doing
- Prepare, coordinate, and deliver FDA REMS submissions, filings, and updates with accuracy and timely completion
- Monitor vendor performance against service level agreements and key performance indicators with monthly governance oversight
- Conduct data reconciliation across compliance, shipment, and KPI sources to maintain program oversight
- Identify, document, and resolve quality issues through corrective and preventive action tracking
- Prepare audit and inspection readiness materials and participate in regulatory inspections
Privacy & handoff
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