Manager, REMS Center of Excellence

Job Description

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

The position will be located at the Princeton, NJ US Headquarters site. Employees may work up to 50% of the month remotely; the role cannot be performed fully 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.

• Serve as the Sandoz safety REMS expert on project/product teams throughout the product life cycle.
• Contribute to the development and implementation of innovative, evidence‑based risk‑management solutions, including enhanced pharmacovigilance and risk minimization activities.
• Provide oversight of the tactical implementation and monitoring of REMS commitments, ensuring timely submission of reporting requirements to FDA.
• Work closely with internal business units—Regulatory Affairs, Medical Affairs, Legal, and Pharmacovigilance— in the development and management of REMS programs.
• Drive execution of REMS development, implementation, and operationalization according to agreed strategies.
• Develop and manage vendor contracts with project team support.
• Manage REMS budgets, review and approve vendor invoices, and approve program deliverables.
• Ensure compliance with REMS regulatory requirements and reporting, and coordinate REMS training across the organization.
• Manage 1–5 REMS programs based on complexity.

• Number of programs and activities executed appropriately.
• Budget managed within allocated spend.
• Program metrics compliance adherence.

Education & Experience:

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

• Regulatory Intelligence & Compliance Mastery:
  Advanced knowledge of FDA REMS requirements, regulatory expectations, and evolving risk‑mitigation standards.
• Vendor & Stakeholder Partnership Management:
  Skilled in establishing productive relationships with vendors, healthcare partners, and internal teams to ensure aligned objectives and seamless delivery.
• Operational Excellence & Process Optimization:
  Expertise in streamlining workflows, optimizing resource allocation, and leveraging data‑driven decision‑making to improve efficiency and scalability.
• 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 and driving cross‑functional collaboration.

• Minimum of 5 years in the pharmaceutical industry.
• Project Management Experience.
• Up to 10% travel required.
• Ability to work independently from a home office when necessary for business purposes.

Up to 10% travel.

The pay range for this position at commencement of employment is expected to be between $91,400 and $169,700 USD per year. Final pay determinations will depend on various factors including geographical location, experience level, knowledge, skills, and abilities. The total compensation package may also include other elements such as sign‑on bonus, restricted stock units, and discretionary awards, in addition to full‑range medical, dental, vision, retirement savings match, and paid time off benefits (vacation, sick time, parental leave).

Employees receive a competitive salary, health insurance coverage for medical, prescription drugs, dental, and vision, a generous company match for retirement savings accounts, and generous paid time off.

Employees will be in an at‑will position, and the Company reserves the right to modify base salary and other discretionary compensation at any time.

On September 30, 2021, Sandoz entered into a 5‑year Corporate Integrity Agreement. Certain positions have responsibilities to support the execution and adherence to CIA obligations, CIA‑related deliverables, and any relevant audit, monitoring or Independent Review Organization (IRO) remediation.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please send an email to reasona or call 1‑609‑422‑4098 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.