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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading Medical Affairs operations, including the design and management of Medical Affairs systems and workflows, while ensuring compliance with U.S. healthcare requirements. Proven ability to develop operational strategies, manage budgets, and oversee cross-functional teams to support scientific communication and product launch readiness.
Highest-signal resume keywords
Medical Affairs Operations LeadershipMedical Information System ManagementBudget Development and ForecastingCross-Functional Team ManagementU.S. Product Launch Readiness
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical Affairs Systems DesignWorkflow ImplementationUser Acceptance TestingOperational Metrics DevelopmentScientific CommunicationProcess ImprovementVendor Performance ManagementRegulatory ComplianceBudget ManagementData Quality Reporting
Soft Skills
Collaborative LeadershipStrong CommunicationAdaptabilityIntegrityAccountability
Industry Keywords
Pharmaceutical IndustryBiotechnologyMedical ReviewIndependent Medical EducationGrants OversightScientific ExchangeNeurologyHeadache ExperienceHealthcare RequirementsOperational Governance
About the role
Key responsibilities & impact- Lead the operational infrastructure supporting Medical Information, medical review, publication processes, independent medical education, and grants oversight
- Establish consistent processes, clear accountability, and high-quality execution across U.S. Medical Affairs activities
- Own Medical Affairs system business requirements, design, implementation, and ongoing management in partnership with IT and relevant functions
- Integrate workflows, technology, vendor oversight, and performance reporting to support compliant scientific communication and launch readiness
- Lead Medical Information operations and workflows supporting publications, independent medical education, grants, and Medical Affairs systems
- Partner with Scientific Communications on scientific content and publication strategy
- Oversee operational governance, vendor performance, and execution across Medical Affairs
- Lead and develop the Medical Affairs operations organization through subordinate managers and team members
- Lead Medical Information operating strategy, including inquiry intake, triage, response workflows, service levels, quality review, reporting, and launch readiness
- Manage external partners supporting Medical Information, publications, congresses, independent medical education grants, investigator-initiated studies, medical sponsorships, and digital resources
- Define scopes, deliverables, budgets, and handoffs
- Support recruitment, onboarding, development, and retention of Medical Affairs talent
- Establish and oversee the Medical Information delivery model, including resources, training, performance evaluation, and capacity planning
- Manage scientific response workflows, approval documentation, distribution, and content updates
- Oversee medical congress logistics, booth operations, materials, and staffing coordination
- Own Medical Affairs system workflow design, implementation, user testing, training, access roles, data quality, reporting, change control, and support
- Establish and manage workflows, documentation, and tracking for scientific medical review, promotional review, and external review committees
- Partner with Medical Affairs, field medical, Scientific Communications, HEOR, Regulatory, Safety, Quality, Legal, Compliance, and IT stakeholders
- Lead development, approval coordination, implementation, training, and periodic review of Medical Affairs SOPs, standards, and policies
- Maintain budget forecasts, vendor performance metrics, launch milestones, and operational risk reporting
- Ensure Medical Affairs activities follow company policies and applicable healthcare requirements
- Coordinate adverse-event and product-complaint escalation, research governance, scientific engagement controls, and responses to unsolicited medical inquiries
- Execute additional responsibilities, initiatives, and special projects as business needs evolve
Requirements
What you’ll need- Bachelor’s degree in life sciences, healthcare, business, law, or a related discipline required
- 8+ years of relevant pharmaceutical or biotechnology industry experience, including substantial Medical Affairs operations experience and oversight of Medical Information or related medical programs
- Minimum of three years of demonstrated leadership of cross-functional operational teams, including external partner management and organizational capability development
- Experience designing, implementing, and managing Medical Affairs systems and workflows, including business requirements, user acceptance testing, training, reporting, and change management in partnership with IT and relevant functions
- Experience supporting U.S. product launch readiness
- Experience managing Medical Information delivery models and operational workflows supporting medical review, publications, congresses, independent medical education, grants, or investigator-initiated studies
- Demonstrated financial and business planning capabilities, including budget development, forecasting, resource allocation, contract oversight, and partner performance management
- Strong program management and analytical skills, including development of dashboards, operational metrics, and process improvements
- Working knowledge of U.S. requirements and company standards applicable to Medical Affairs activities, scientific exchange, and Medical Information
- Strong communication skills and scientific literacy
- Neurology or headache experience is preferred
- Experience building capabilities in a growing biopharmaceutical organization is highly desirable
- Demonstrated integrity, accountability, adaptability, collaborative leadership, and commitment to patients
- Demonstrated ability to develop and articulate company-wide Medical Affairs operations strategy, vision, and direction
- Proven experience negotiating and influencing at the executive level
Benefits
Comp & perks- Health Insurance
- Dental & Vision Insurance
- Healthcare & Dependent Care FSA
- Employee Assistance Program (EAP)
- 401(k) Savings Plan
- Long-term Incentive Plan
- Life Insurance
- Accident & Disability Insurance
- Telemedicine
- Generous Paid Time Off
- Company Holidays
