REMS Program Manager

Rangam; Lawrenceville (NJ); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a dynamic Program Manager to lead critical initiatives within their Risk Evaluation and Mitigation Strategies program. This role is crucial in ensuring regulatory compliance, driving operational efficiency, and managing cross-functional teams. You will oversee the execution of various REMS programs, track milestones, and present updates to stakeholders. With a focus on continuous improvement, you will also manage a cloud-based platform, ensuring its stability and adoption. If you have a strong background in program management within the pharma or biotech sectors and possess excellent leadership skills, this opportunity is perfect for you.

Qualifications

• 10+ years in program management within the pharma/biotech industry.
• Strong knowledge of regulatory frameworks and REMS processes.

Responsibilities

• Manage end-to-end execution of REMS programs and ensure compliance.
• Deliver executive-level reports and lead governance meetings.

Skills

Program Management

Stakeholder Management

Cross-functional Leadership

Regulatory Compliance

Risk Management

Cloud Systems Management

Education

Bachelor’s degree in Business

Bachelor’s degree in Life Sciences

Bachelor’s degree in Healthcare Management

Master’s degree

PMP certification

Tools

CAMUNDA Platform

Job description

We're hiring a Program Manager to lead key initiatives within our Risk Evaluation and Mitigation Strategies (REMS) program, overseeing REMS CAR-T, REMS MAVA, REMS IMiDs, and REMS CELMoDs. You’ll play a pivotal role in ensuring regulatory compliance, driving efficiency, and managing cross-functional teams.

Key Responsibilities:

REMS Program Oversight

• Manage end-to-end execution of REMS CAR-T, MAVA, IMiDs & CELMoDs programs
• Track milestones, report outcomes, and ensure compliance with regulatory guidelines
• Present updates and dashboards to internal and external stakeholders

CAPA Management

• Lead resolution of CAPAs from the Global REMS IMiDs P1 investigation
• Track corrective actions and process improvements

System Management (Post-Go Live – CAMUNDA Platform)

• Monitor performance of the new cloud-based REMS platform
• Partner with IT to resolve issues and roll out system enhancements
• Ensure adoption and stability of the cloud solution
• Work with process improvement experts (including Ernst & Young)
• Analyze current workflows and identify operational improvements

Stakeholder Communication & Reporting

• Deliver executive-level reports, program insights, and timely updates
• Lead governance meetings, document action items, and track follow-ups
• Act as the escalation point for critical updates
• Proactively identify and mitigate risks within the REMS ecosystem
• Conduct root cause analysis and develop contingency plans

Qualifications:

Education:

• Bachelor’s degree in Business, Life Sciences, or Healthcare Management required
• Master’s degree or PMP certification preferred

Experience:

• 10+ years in program management (pharma/biotech industry)
• Strong knowledge of regulatory frameworks and REMS processes
• Experience managing post-implementation systems in a cloud environment
• Skilled in stakeholder management and cross-functional leadership

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Research and Science

Industries

Pharmaceutical Manufacturing and Biotechnology Research