Manager, REMS Center of Excellence
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Job Description
Manager, REMS Center of Excellence managing risk evaluation strategies for Sandoz's generic and biosimilar portfolios. Collaborating internally and externally to ensure regulatory compliance and effective risk management.
Responsibilities:
- Manage Risk Evaluation and Mitigation Strategies (REMS) in the Sandoz generic and biosimilar portfolios
- Serve as the Sandoz safety REMS expert on project/product teams throughout the product life cycle
- Provide oversight of the tactical implementation and monitoring of REMS commitments
- Work closely with internal business units, including Regulatory Affairs, Medical Affairs, Legal, and Pharmacovigilance
- Drive execution of REMS development, implementation, and operationalization according to agreed strategies
- Develop and manage vendor contracts
- Manage REMS budgets, review and approve vendor invoices, and program deliverables
- Ensure compliance with REMS regulatory requirements and reporting
- Coordinate REMS training across the organization
Requirements:
- RN, MS, MPH, MBA, or BS with considerable experience
- Minimum of 2 years supporting REMS programs
- Advanced knowledge of FDA REMS requirements, regulatory expectations, and evolving risk-mitigation standards
- Skilled in establishing productive relationships with vendors, healthcare partners, and internal teams
- Expertise in streamlining workflows, optimizing resource allocation, and leveraging data-driven decision-making
- Deep understanding of project management methodologies and best practices
- Ability to develop and execute high-level strategies for product launches
- Minimum of 5 years in pharmaceutical industry (preferred)
Benefits:
- Health insurance coverage for medical, prescription drugs, dental and vision
- Generous company match for retirement savings accounts
- Generous paid time off
- Hybrid work policy that combines a mix of in-person and remote work
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