Manager, REMS Center of Excellence (Remote)

Job Description Summary

To work collaboratively with internal and external stakeholders to manage Risk Evaluation and Mitigation Strategies (REMS) in the Sandoz generic and biosimilar portfolios.

Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally.

Join us, the future is ours to shape!

 

Position Location:

This role will have the ability to be located remotely.

Must be authorized to work in the U.S.  U.S. work visa sponsorship is not available for this role now or in the future.

Major Accountabilities / Your Key Responsibilities:

Your responsibilities include, but not limited to:

• 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
   

 Key performance indicators:

• Number of programs and activities executed appropriately

• Budget managed within allocated spend

• Program metrics

• Compliance adherence

• Communication and collaboration with internal/external colleagues

What you’ll bring to the role:

 

Required Qualifications:

Education & Experience (Required):

• 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.

Preferred Requirements:

• Minimum of 5 years in pharmaceutical industry

• Project Management Experience

 

Travel Requireme