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Manager, REMS Center of Excellence (Remote)

Sandoz -
Princeton, NJ

Apply Now

Job Details

Full-time
$91,400 - $169,700 a year

Benefits

Health insurance
Dental insurance
RSU
Paid time off
Parental leave
Vision insurance

Qualifications

New product launch strategy
Resource allocation (project management tasks)
Team leadership
Workflow management (operations management method)
Drug regulation
Process design
Process improvement
Vendor compliance management
Policy & process development
Project management experience in healthcare
Vendor relationship management
Regulatory readiness in healthcare
Managing projects
Operational excellence initiatives
Clinical program risk management
Healthcare compliance
Cross-functional communication

Full 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 Requirements: Up to 10%

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

You’ll 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$91,400- $169,700USD/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 4.15.24[16].pdf

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!

Apply Now

Refine Your Search

Center Manager Development jobs

Manager, REMS Center of Excellence (Remote)

Program Manager

Program Manager EHR Trainer

Business Development Manager

Managing Director, Head of Philippines

Senior Sales Leadership Trainer, US

Senior Manager, Global Development Quality Assurance (GCP)

Director, Utilization Management Operations

Brain Injury and Health Project Manager

Regional Manager- Volunteer Development Team, Northeast (Albany, New York)

Assistant Nurse Manager - NICU - Hopewell - Full Time - DAYS

Nurse Unit Manager LPN

Manager of Pediatric Acute Care Nurse Practitioners and Physician Assistants - Cardiac Center

Nurse Unit Manager RN

PACE Medical Director, Jordan Valley Senior Care

Clinical Director (PSP)

Nurse Educator (RN)

RN Manager

Rehab Manager-OT/PT

Quality Improvement & Data Analytics Manager

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