Pharma REMS PM

Top skill is Regulatory Expertise in Pharma environment: Previous experience with regulatory compliance programs, particularly in REMS or similar risk management initiatives.

Overview:
The Program Manager for the REMS (Risk Evaluation and Mitigation Strategies) program will be responsible for the oversight and management of multiple REMS components, including REMS CAR-T, REMS MAVA, and REMS IMiDs. This role requires a strategic leader with strong project management skills to ensure compliance, efficiency, and continuous improvement within the REMS program.

Key Responsibilities:

Program Oversight:
Manage and oversee the REMS CAR-T, REMS MAVA, REMS IMiDs, and REMS CELMoDs programs, ensuring alignment with regulatory requirements and business objectives.
Drive program outcomes by ensuring each program meets its intended deliverables within expected timelines.
Provide regular, detailed reporting on program status, progress, and key milestones to stakeholders.

CAPA Management: Oversee resolution of Corrective and Preventive Actions (CAPAs) resulting from the Global REMS IMiDs investigation triggered by a P1 incident in January 2025.

Management of Post Go-Live Issues for CAMUNDA: Oversee post-production activities for the Global IMiDs REMS platform that transitioned to a cloud-based system on January 27, 2025. This includes:
- Monitoring system performance and stability in the cloud environment
- Managing ongoing optimization efforts and address any technical issues
- Coordinating with IT teams on maintenance, updates, and enhancements
- Ensure business continuity and user adoption of the cloud-based solution

SWAT Team Coordination: Collaborate with the SWAT team, including members from Ernst & Young, to analyze program and business processes, identifying opportunities for efficiency and process improvements.

Stakeholder Engagement & Communication:
Engage with internal and external stakeholders to align program objectives, priorities, and deliverables.
Facilitate clear communication channels between internal teams and external partners.
Deliver integrated program-level reporting tailored to stakeholder needs by:
o Providing timely status updates with appropriate level of detail for each audience.
o Balancing sufficient context with clear high-level messaging to ensure key takeaways are clear
o Highlighting critical information without overwhelming recipients with unnecessary details
o Adapting communication style and content to effectively inform decision-makers at all organizational levels
Coordinate and manage regular governance sessions with key stakeholders (such as Steering Committee meetings) by:
o Developing structured agendas
o Capturing and documenting decisions, action items, and accountabilities
o Following up on commitments to ensure momentum is maintained between meetings
o Serving as the primary escalation point for critical program updates or concerns

Risk Governance:
Implement proactive risk identification and mitigation strategies
Lead root cause analysis for any program issues
Develop contingency plans for high-risk areas within the REMS ecosystem

Qualifications:
Educational Background: Bachelor's degree in a relevant field (e.g., Business Administration, Project Management, Healthcare Management). Advanced degree preferred.

Professional Experience:
Industry Experience: Minimum of 10 years of experience in program management, preferably within the healthcare or pharmaceutical industry
System Management: Demonstrated experience in post-implementation system management
Regulatory Expertise: Previous experience with regulatory compliance programs, particularly in REMS or similar risk management initiatives\