Manager, REMS Center of Excellence

U023 (FCRS = US023) Sandoz Inc; Princeton (NJ); Hybrid; USD 91,400 - 169,700; Full time

Benefits offered by this job

Health insurance

Generous paid time off

Retirement savings match

Job summary

Sandoz Inc is hiring for a role focused on managing Risk Evaluation and Mitigation Strategies (REMS) within the Princeton, NJ headquarters. This position involves collaborating with various stakeholders to ensure compliance and operational effectiveness of REMS programs.

The ideal candidate will have a strong background in regulatory affairs, compliance, and project management, with at least 2 years of experience in REMS. The company offers competitive compensation including salary, health benefits, and paid time off.

Qualifications

• Minimum of 2 years supporting REMS programs.
• Advanced knowledge of FDA REMS requirements.
• Skilled in establishing productive relationships.

Responsibilities

• Serve as the Sandoz safety REMS expert on project/product teams.
• Contribute to the development of risk-management solutions.
• Provide oversight of REMS commitments and submissions.

Skills

Regulatory Intelligence & Compliance

Vendor Management

Operational Excellence

Project Management

Strategic Leadership

Education

RN, MS, MPH, MBA, or BS with considerable experience

Job description

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.

Location

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.

Key Responsibilities

• 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.

Key Performance Indicators

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

Required Qualifications

Education & Experience: 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.
• 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.

Preferred Requirements

• 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.

Travel Requirements

Up to 10% travel.

Benefits & Compensation

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.

Corporate Integrity Commitment

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.

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

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 [e-mail] 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.