REMS Program ManagerRangam • Lawrenceville, NJ, US

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REMS Program Manager

Rangam • Lawrenceville, NJ, US

17 hours ago

Job type

Full-time

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

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Program Manager • Lawrenceville, NJ, US

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