Manager, REMS Center of Excellence

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Oversee Risk Evaluation and Mitigation Strategies (REMS) within the Sandoz generic and biosimilar product lines.

• Act as the Sandoz safety REMS authority on project/product teams throughout the entire product lifecycle.

• Aid in the creation and execution of innovative risk management strategies.

• Supervise the tactical execution and monitoring of REMS obligations.

• Collaborate closely with internal departments to design and manage REMS initiatives.

• Propel the execution of REMS development, implementation, and operational processes.

⛳️ Requirements

• RN, MS, MPH, MBA, or BS with substantial relevant experience.

• At least 2 years of experience in supporting REMS programs.

• In-depth knowledge of FDA REMS regulations, compliance expectations, and the evolving landscape of risk-mitigation standards.

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

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

• Strong grasp of project management principles and best practices.

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

🏝️ Benefits

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

• Generous company contributions to retirement savings accounts.

• Extensive paid time off.

• Hybrid work policy offering a blend of in-person and remote work for employee flexibility.