Overview

The Specialist, Medical Affairs Operations is responsible for the oversight, coordination, and execution of key operational activities within the Medical Affairs department. This role ensures compliant and efficient management of medical grant requests, investigator-initiated studies (IISs) and vendor contract agreements. This individual will work cross-functionally with Medical Affairs, Legal, Compliance, Finance and external partners to support strategic objectives while maintaining adherence to corporate policies and industry guidelines.

Responsibilities

• Oversee operational management of key departmental projects, contracts, medical grant requests, investigator-initiated studies (IISs), and associated systems platforms,
• Lead operational aspects of our IIS program including web-portal submissions, review committee coordination, adherence to evaluation criteria, facilitation of contract execution, and tracking study milestones/payments,
• Coordinate the end-to-end process for medical education requests which include assessment of proper documentation, grant committee review, tracking of approvals/denials, and timely external communication,
• Orchestrate the development, review and execution of vendor contracts and/or proposals including MSAs, SOWs, RFPs, while maintaining accurate documentation and proper reporting for audit readiness,
• Support adherence to the departmental budget interfacing with the Medical Affairs team, outside vendors, and members of the finance team to help ensure deliverables, timelines, and budgets are met,
• Manage all departmental purchase requisitions, purchase orders, and contracts to ensure compliance, documentation, and efficient workflows,
• Develop and implement process improvements with a growth mindset to enhance efficiency, transparency, and scalability of Medical Affairs operations in a burgeoning company.

Qualifications

• Bachelor's degree required, Master's Degree preferred
• Operational experience with IISs, educational grants, and/or vendor contract agreements is preferred,
• Ideal candidates will have experience using system platforms (e.g., Coupa, Ariba, ComplianceWire, LMS systems),
• Experience coordinating with external and internal stakeholders in the pharmaceutical industry,
• Strong communication and presentation skills with the ability to effectively communicate to a wide variety of audiences including senior management,
• Excellent problem-solving skills and attention to detail,