Manager

Description

• Serving as the Sandoz safety REMS expert on project/product teams throughout the product life cycle and contributing to the development and implementation of innovative, evidence-based risk management solutions, including enhanced pharmacovigilance and risk minimization activities that will ensure optimized benefit with minimized risk.
• Providing oversight of the tactical implementation and monitoring of REMS commitments including ensuring timely submission of reporting requirements to FDA.
• Working closely with internal business units, including but not limited to Regulatory Affairs, Medical Affairs, Legal, and Pharmacovigilance in the development and management of REMS programs.
• Driving execution of REMS development, implementation, and operationalization according to agreed upon strategies.
• Developing and managing vendor contracts with the support of project teams.
• Managing REMS budgets, reviewing and approving vendor invoices, and reviewing and approving program deliverables
• Ensuring compliance with REMS regulatory requirements and reporting, and coordinating REMS training across the organization
• Managing 1 – 5 REMS programs based on complexity

Qualifications

• RN, MS, MPH, MBA, or BS with considerable experience
• Minimum of 2 years supporting REMS programs

Key Capabilities Required

• Regulatory Intelligence & Compliance Mastery: Advanced knowledge of FDA REMS requirements, regulatory expectations, and evolving risk‑mitigation standards, enabling proactive compliance, audit readiness, and high‑quality execution of REMS obligations.
• Vendor & Stakeholder Partnership Management: Skilled in establishing productive relationships with vendors, healthcare partners, and internal teams to ensure aligned objectives, consistent performance, and seamless delivery of REMS program components.
• Operational Excellence & Process Optimization: Expertise in streamlining workflows, optimizing resource allocation, and leveraging data-driven decision-making to improve efficiency and scalability of launch processes.
• Project & Portfolio Management Expertise: Deep understanding of project management methodologies and best practices to ensure seamless execution, risk mitigation, and on-time delivery.
• Strategic Leadership & Vision: Ability to develop and execute high-level strategies for product launches, aligning project goals with overall business objectives while driving cross-functional collaboration.