Rangam
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr