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Director Patient Engagement and Consumer Marketing

Amgen · Wilmington, DE

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RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.

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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What RoleLantern checked

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Date posted1 day ago
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