Manage the implementation of all operational components for medical affairs projects, including coordinating and negotiating CDAs, contracts, and sponsorship agreements with both external vendors and internal stakeholders
Collaborate with compliance and finance teams to ensure that thorough Fair Market Value assessments are performed on all external payments in accordance with company and industry standards
Uphold precise documentation and reporting practices to promote compliance and transparency, ensuring adherence to regulations such as FMV and the Sunshine Act
Design and roll out operational policies, procedures, and best practices aimed at enhancing efficiency, quality, and regulatory compliance across Medical Affairs operations
Evaluate vendor proposals, statements of work, and contracts for their operational viability and cost-effectiveness
Manage and track vendor SOWs against actual work performed and verify vendor invoices working closely with finance for payment
Lead the development of metrics tracking and dashboards to provide leadership with updates on project progress, key performance indicators, and outcomes
Foster clear and effective communication among internal teams, external stakeholders, and field medical staff to support unified and efficient execution of Medical Affairs activities
Stay informed about industry developments, changes in regulations, and emerging best practices to drive continuous improvement within Medical Affairs operations
Act as a central point for resolving issues, managing risks, and escalating operational challenges as needed
Assist in organizing advisory boards, patient advocacy programs, congress (national and regional) planning, and other significant Medical Affairs initiatives and events
Take part in strategic planning, contributing ideas to help shape the future direction of Medical Affairs within the organization
Proactively seek opportunities for process improvements and lead initiatives to achieve operational excellence in Medical Affairs
Use data analytics and stakeholder feedback to measure program success and suggest enhancements that meet organizational objectives and regulatory obligations
Work closely with IT partners to enable digital transformation and integrate systems supporting Medical Affairs functions

Requirements

Bachelor's degree in Life Science, Healthcare, or related field, advanced degree preferred
5+ years of experience in Medical Affairs, Clinical Operations, or a related field in the pharmaceutical or biotech industry, oncology experience preferred
Strong administrative, organizational, and project coordination skills
Project management certification (PMP or equivalent) is a plus
Excellent written and verbal communication skills
Proficiency in using project management and budgeting tools
Familiarity with medical terminology and clinical research practices is a plus
Experience in pre-launch and launch activities preferred
Ability to work independently, prioritize tasks, manage multiple projects simultaneously, and maintain attention to detail in a dynamic environment
Display proficiency in utilizing digital tools and platforms to streamline workflows and enhance the efficiency of Medical Affairs operations
Knowledge of Medical, Legal, Review (MLR) processes preferred

Benefits

Actual compensation packages based on skill set and experience
Bonus
Stock options
Benefits
Other applicable variable compensation

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

project managementdata analyticsvendor managementcontract negotiationFair Market Value assessmentregulatory compliancemetrics trackingclinical research practicesprocess improvementbudgeting

Soft Skills

organizational skillsproject coordinationcommunication skillsproblem-solvingattention to detailindependent workprioritizationcollaborationleadershipstrategic planning

Certifications

Bachelor's degreeadvanced degreeProject Management Professional (PMP)