Program Manager

Description

Candidates must be 50% onsite at Lawrenceville or Giralda Farms.

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:

• Providing timely status updates with appropriate level of detail for each audience.
• Balancing sufficient context with clear high-level messaging to ensure key takeaways are clear
• Highlighting critical information without overwhelming recipients with unnecessary details
• 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:

• Developing structured agendas
• Capturing and documenting decisions, action items, and accountabilities
• Following up on commitments to ensure momentum is maintained between meetings
• 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