Manager, REMS Center of Excellence

Job Description Summary

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 position will be located at the Princeton NJ US Headquarters site.

Our Sandoz flexible hybrid working approach allows US office-based employees to work up to 50% of their monthly workday remotely. This role will not 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 youll 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 riskmitigation standards enabling proactive compliance audit readiness and highquality 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-drivendecision-making to improve efficiency and scalability of launch processes.

• Project & Portfolio Management Expertise:
  Deep understanding of project management methodologies and best practices to ensure seamlessexecution risk mitigation and on-time delivery.

• Strategic Leadership & Vision:
  Ability to develop and execute high-level strategies for product launches aligning project goalswith overall business objectives while driving cross-functional collaboration.

Preferred Requirements:

• Minimum of 5 years in pharmaceutical industry

• Project Management Experience

Travel Requirements: Up to 10%

• Ability to work independently from a home office when necessary for business purposes.

Youll Receive:

Sandoz offers a generous employee benefits package that includes 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. We also follow a hybrid work policy that combines a mix of in-person and remote work to allow our employees flexibility.

The pay range for this position at commencement of employment is expected to be between $91400-$169700 USD/year; however while salary ranges are effective from 1/1/26 through 12/31/26 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

On September 30 2021 Sandoz entered into a 5-year Corporate Integrity Agreement. Certain positions will 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.

Sandoz - Notice at Collection to Employees Applicants

Why Sandoz

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz a leader in this sector provided more than 900 million patient treatments across 100 countries in 2024 and while we are proud of this achievement we have an ambition to do more!

With investments in new development capabilities production sites new acquisitions and partnerships we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost high-quality medicines sustainably.

Our momentum is powered by an open collaborative culture driven by our talented and ambitious colleagues who in return for applying their skills experience an agile and collegiate environment with impactful flexible-hybrid careers where diversity is welcomed and where personal growth is supported!

Join us!

EEO Statement:

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.

Accessibility and reasonable accommodations

Sandoz Inc. is committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to or call 1- and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired