Program Manager

Job Description

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

Qualifications

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

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.