Senior Manager, Professional Relations Independent Medical Education (PRIME) and Medical Review Operations

Role Summary

Senior Manager to lead and optimize the operational, compliance, and governance processes for Independent Medical Education (IME) grants, Medical Affairs-led Sponsorships and Medical Review Operations. This role ensures strategic alignment, regulatory compliance, and operational excellence across neuroscience, immunology and other therapeutic areas. The ideal candidate has deep expertise in Medical Affairs operations, grant and sponsorship management, and cross-functional collaboration within a regulated environment.

Responsibilities

• Manage the full lifecycle of IME grants and Medical Affairs-led sponsorships, including intake, triage, compliance review, approvals, contracting, and reconciliation.
• Serve as operational lead and facilitator for formal review sessions (e.g., Grant Review Committee [GRC]), ensuring timely reviews, quorum management, and documentation of decisions.
• Coordinate submission reviews across U.S., and International Medical Affairs teams, adhering to defined timelines and governance standards.
• Partner with cross-functional stakeholders (Legal, Compliance, Finance, Medical Strategy) to ensure strategic alignment and transparency in funding decisions.
• Maintain a schedule of supported educational events and track outcomes across indications and molecules.

Systems & Compliance Oversight

• Monitor and manage submissions using electronic platforms (e.g., Veeva Vault PromoMats, Veeva Vault MedComms, Iqvia).
• Ensure accurate classification of grants (e.g., accredited vs. non-accredited), completion of due diligence (e.g., debarment screenings), and documentation of decisions.
• Collaborate with Legal to finalize Letters of Agreement (LOAs), Statement of Work (SOW) and amendments.
• Oversee program delivery to ensure evidence-based, fair, and balanced content in accordance with policy guidelines.
• Lead reconciliation efforts post-event, confirming proper fund usage, metrics reporting, and return of unused funds.

Strategic Planning & Reporting

• Contribute to annual strategic planning, including therapeutic area needs assessments, budget forecasting, and development of areas of interest.
• Develop and maintain standardized templates, checklists, and SOPs to drive consistency and efficiency.
• Analyze portfolio metrics to identify trends, gaps, and opportunities for process improvement.
• Ensure audit readiness and compliance with transparency reporting requirements.

Cross-Functional Collaboration & Continuous Improvement

• Identify and implement process improvements related to IME and sponsorship workflows.
• Update documentation and workflow diagrams to support business continuity and operational excellence.
• Respond to reported issues and collaborate with internal and external stakeholders to resolve them.
• Partner with the IME Director and other leaders on strategic initiatives and special projects.

Medical Review Operations

• Coordinate inter-team scheduling across multiple inputs to ensure consistent coverage for project reviews. Maintain and optimize the Medical Review team calendar to support operational efficiency.
• Facilitate clear and timely communication of decisions across Medical Review sub-teams. Ensure documentation of outcomes and alignment with governance processes.
• Serve as the primary Medical Affairs contact for Marketing and Material Review Committee Operations to support project prioritization, forecasting, and strategic alignment.
• Lead enhancements to Veeva Vault workflows and develop associated process documentation to support scalable and compliant review operations. Experience with Microsoft tools and Artificial Intelligence-enabled platforms is preferred to drive automation and efficiency.
• Manage administrative tasks related to quarterly Medical Review Community Meetings, including scheduling, agenda coordination, and follow-up actions.

Qualifications

Education & Experience

• Bachelor‚Äôs degree in Life Sciences, Business Administration, or related field (advanced degree preferred).
• Minimum 3‚Äì5 years of experience in Medical Affairs operations, medical education, or grants/sponsorship management in the pharmaceutical/biotech or healthcare industry. Experience in operational support of medical material review is desirable.

Technical Skills

• Proficiency in Microsoft 365 (Excel, PowerPoint, Word, Outlook); advanced Excel skills (Pivot Tables, Macros, VBA) preferred.
• Experience with Microsoft tools related to artificial intelligence (AI) and familiarity with integrating AI capabilities into operational workflows.
• Experience with grant management systems (e.g., CyberGrants, Iqvia).
• Familiarity with reporting tools (e.g., SmartSheets, Mondays.com).
• Experience with Veeva Vault PromoMats and Veeva Vault MedComms.

Knowledge & Competencies

• Deep understanding of IME, CME, and third-party sponsorship standards, including U.S. and ex-U.S. compliance regulations (e.g., Sunshine Act, EFPIA, OIG, PhRMA, ACCME).
• Strong project management, facilitation, and documentation skills.
• Ability to work independently and manage multiple priorities in a fast-paced, regulated environment.
• Experience coordinating across matrixed global teams and managing external education providers.

Additional Information

• Occasional travel (<10%) may be required for in-person meetings or congresses.