Director Patient Engagement and Consumer Marketing

Amgen seeks a Manager REMS to lead Risk Evaluation and Mitigation Strategy program operations, ensuring FDA compliance and patient safety across the medicine lifecycle. The role emphasizes operational excellence, vendor oversight, regulatory submissions, and data-driven decision-making to maintain reliable access to therapies.

Responsibilities

• 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

Requirements

• 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