Manager, REMS Center of Excellence

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate effectively with both internal and external stakeholders to oversee Risk Evaluation and Mitigation Strategies (REMS) within the Sandoz generic and biosimilar portfolios.

• Act as the Sandoz safety REMS authority on project and product teams throughout the entire product life cycle.

• Provide oversight for the tactical execution and monitoring of REMS obligations.

• Develop and manage vendor contracts in collaboration with project teams.

• Ensure adherence to REMS regulatory requirements and reporting standards.

• Contribute to the design and implementation of innovative, evidence-based solutions for risk management.

• Lead the execution of REMS development, implementation, and operationalization in line with established strategies.

⛳️ Requirements

• RN, MS, MPH, MBA, or BS with significant experience.

• At least 2 years of experience supporting REMS programs.

• Extensive knowledge of FDA REMS requirements, regulatory expectations, and evolving risk-mitigation standards.

• Proficient in building effective relationships with vendors, healthcare partners, and internal teams.

• Expertise in enhancing workflows, optimizing resource usage, and utilizing data-driven decision-making.

• Comprehensive understanding of project management methodologies and best practices.

• Capability to formulate and implement high-level strategies for product launches.

• Willingness to travel up to 10% as required.

🏝️ Benefits

• Health insurance coverage for medical, prescription drugs, dental, and vision.

• A substantial company match for retirement savings plans.

• Generous paid time off.

• A hybrid work policy that combines in-person and remote work, providing employees with flexibility.