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REMS Program Manager
REMS Program ManagerRangam • Lawrenceville, NJ, US
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REMS Program Manager

REMS Program Manager

Rangam • Lawrenceville, NJ, US
Hace 2 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

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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