Senior Manager / Associate Director, Medical Affairs Operations

Role Summary

The Senior Manager / Associate Director, Medical Affairs Operations will play a key cross-functional role supporting the development, coordination, and execution of strategic medical initiatives across medical affairs. The role serves as a core liaison between external vendors/stakeholders, field medical teams, and internal stakeholders, driving medical insights and execution excellence to support the organization’s strategic goals. It also involves designing and managing the Medical Affairs Group’s Operational infrastructure and supporting grants, IITs, sponsorships, and the medical/regulatory/legal review process.

Responsibilities

• Be the medical member of the medical/regulatory/legal (MRL) review committee
• Provide project management support to the Medical Affairs organization in alignment with its objectives and strategies
• Own, manage, oversee and update the library of MSL training material, standard response letters, medical presentation material, contracts, publications and other materials
• Manage operational and functional aspects of congresses, advisory boards, and complex meeting planning and execution
• Ensure timelines, initiatives and resources align with Home Office Medical Affairs and Field MSL objectives, including congress planning and medical booth support
• Develop and maintain a calendar of meetings across programs, including congress and internal meetings
• Liaise with HCPs, Legal and Contacts teams by submitting and tracking Medical Affairs contracts for timely submission and full execution
• Coordinate the development of Standard Operating Procedures (SOPs) and compliance updates as needed
• Lead and drive medical affairs in identifying potential investigators and research projects, grants, IITs, and sponsored study site identification

Qualifications

• Advanced healthcare degree, including PharmD, Ph.D., or MD, required
• 4+ years of experience in the field of medical affairs or medical affairs operations
• Experience in rare diseases, especially rare neuromuscular diseases, preferred
• 3+ years of project and operations management experience, including at least 3 years in Biotech or Pharmaceutical industry, required
• At least 3 years of active working experience in Medical Affairs organizations and functions (including HCP interactions, MSLs, content management, Sunshine Act Reporting, Agency Management, Contract management, KOL/HCP management) required
• Proficient in managing medical affairs operations systems (e.g., Veeva CRM, Veeva Promomats, document management systems)
• Proficient in managing DocuSign, Concur, Coupa, and vendor management systems
• Knowledge of pharmaceutical regulations, regulatory compliance and quality assurance
• Able to manage budgets, purchase orders, statements of work, and payments on time
• Ability to manage simultaneous priorities, changing deadlines, and limited resources
• High sense of urgency, attention to detail, and commitment to execution
• Strong organizational and prioritization skills
• Excellent communication and interpersonal skills; highly organized and detail-oriented
• Advanced knowledge of Microsoft Office (Word, Access, Excel, PowerPoint, Teams)
• Ability to influence through clear communication and logical reasoning
• Ability to participate in scientific dialogue with KOLs and researchers
• Travel – 20% of time for travel

Skills

• Project and operations management
• Medical affairs systems management (Veeva CRM, Veeva Promomats, document management)
• Contract management and vendor management
• Regulatory compliance and quality assurance
• Budgeting and financial processes (POs, SoWs, payments)
• Strong communication, networking, and stakeholder management
• Scientific dialogue with KOLs and researchers

Education

• Advanced healthcare degree required (PharmD, Ph.D., or MD)

Additional Requirements

• Travel – 20% time for travel