- Provide strategic project management support across Medical Affairs and cross-functionally
- Manage Company Sponsored Phase 4 study operations end to end, including CRO oversight and cross-functional alignment
- Operationalize Medical Affairs planning, including budget planning with Medical Directors
- Support congress planning, reports, and congress-specific training materials
- Maintain Medical Affairs SharePoint databases, budgets, medical resources, and departmental report repositories
- Create project timelines, monitor strategic project progress, and ensure deliverables are completed on time and within budget
- Support advisory boards, publications, and congress meetings
- Lead development of the monthly Medical Affairs dashboard
- Maintain calendars of program, congress, and internal meetings
- Plan, implement, and maintain departmental platforms
- Maintain quarterly business updates and support preparation for Executive Leadership Team and Senior Leadership Team presentations
- Author and maintain Medical Affairs operating processes and SOPs, ensuring audit- and launch-readiness
- Build operating processes and systems in a fast-moving, high-growth environment
- Establish process improvements, incorporate new technologies, and develop communication tools for cross-functional partners
- Support publication processes and create materials for internal meetings using PowerPoint, Smartsheet, and other tools
Requirements
- Bachelor’s degree required; advanced degree preferred
- Minimum of 5 years of relevant operational experience in the pharmaceutical or biotech industry
- Project management and resource planning/management experience; PMP or other project management certification is a plus
- Minimum of 8 years of company sponsored study management experience within Clinical Operations or Medical Affairs or combination
- Strong knowledge of and ability to implement Medical Affairs concepts and operational practices
- Proven experience managing and interacting with medical affairs vendors
- Ability to represent Medical Affairs project management activities with broader Project Management and cross-functional teams
- Strong cross-functional collaboration skills
- Proficiency in project management software and tools and Microsoft Office Suite; experience with Smartsheet
- Excellent written, verbal, and communication skills
- Ability to work independently, prioritize complex information, and problem solve
- Ability to thrive in a fast-paced environment, handle multiple activities, prioritize, and pivot as necessary
- Ability to travel 10–20%
Core Competencies
Demonstrates expertise in strategic project management within Medical Affairs, including end-to-end study operations, budget planning, and cross-functional collaboration. Proficient in developing and maintaining operating processes, dashboards, and communication tools to support high-growth environments.
Highest-signal resume keywords
- Project Management
- Medical Affairs Operations
- CRO Oversight
- Cross-Functional Collaboration
- PMP Certification
ATS Optimization Keywords
Hard Skills
- Project Management
- Resource Planning
- Study Management
- Medical Affairs Concepts
- Process Improvement
- Budget Planning
- SOP Development
- Audit Readiness
- Publication Processes
- Timeline Creation
Soft Skills
- Excellent Communication Skills
- Problem Solving
- Independent Work
- Prioritization
- Adaptability
Certifications & Qualifications
Industry Keywords
- Pharmaceutical Industry
- Biotech Industry
- Clinical Operations
- Medical Affairs
- Vendor Management
Tools & Technologies
- Microsoft Office Suite
- Smartsheet
- SharePoint
- Project Management Software