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Project Manager Medical Affairs (M/F/D)
The Medical Affairs Operations Manager partners with key stakeholders, including Disease Area and Regional Medical teams, to drive operational excellence across annual medical planning, launch readiness, budgeting, and the delivery of key Medical Affairs milestones. The role governs the Medical Affairs Strategy Team forums. Owning membership, charter, cadence, and outputs, and managing the business process calendar to ensure insight generation, evidence generation planning, publication planning, and medical strategy documents are delivered on time, in scope, and with high quality in a global, matrixed environment.
Tasks:
1) Governance & cross functional orchestration
• Coordinate and lead Medical Affairs Strategy Team (MAST) forums for assigned Disease Area(s): maintain current membership, charter, standing agenda, and ensure meetings occur at the defined cadence with documented decisions and actions.
• Establish and maintain a RACI and governance rhythm that enables rapid issue escalation, risk/decision tracking, and cross functional alignment (Medical, Clinical, Publications, HEOR, Commercial, Regions, and enabling functions).
2) Annual planning, launch readiness & process ownership
• Implement and maintain global operational templates (e.g., annual medical plans, launch playbooks, budget worksheets) within assigned Disease Area(s) (DAs); ensure consistent usage and version control.
• Own the Medical Affairs business process calendar to drive on time inputs/outputs across insights → evidence generation planning → publication planning → medical strategy documents; coordinate dependencies with global/regional partners.
3) Budget, timeline & performance management
• Partner with finance and DA leads to plan, track, and reconcile budgets; surface variances, risks, and opportunities; maintain auditable documentation.
• Build and maintain milestone plans/Gantt schedules; monitor critical path, mitigate risks, and publish status dashboards and executive summaries.
4) Grants & Investigator Initiated Studies (IIS) support
• Partner with Grants/IIS operations to coordinate intake, review calendars, and milestone tracking; ensure alignment with medical strategy and governance requirements.
• Facilitate operational readiness (e.g., SOP adherence, documentation completeness, and cross functional handoffs) for grants/IIS processes.
5) Quality, compliance & inspection readiness
• Ensure processes and deliverables meet internal SOPs and external standards; maintain audit ready records for plans, forums, budgets, and decisions.
• Drive continuous improvement in templates, SOPs, and ways of working; capture lessons learned and standardize best practices.
6) Tools, reporting & communication
• Build lightweight dashboards and trackers (e.g., Smartsheet/MS Project/Gantt, budget trackers, KPI scorecards) to enable transparent decision making.
• Synthesize updates for senior Medical leadership—highlighting progress, risks, decisions needed, and mitigation plans.
Required Qualifications:
Bachelor’s degree required. Advanced degree and/or PMP or equivalent project management certification desirable.
10+ years of relevant experience in pharma/biotech within Medical Affairs operations, clinical/medical program management, or closely related functions in a global, matrixed setting.
Proven ability to lead cross-functional, complex initiatives without direct authority; strong stakeholder management across global/regional partners.
Demonstrated excellence in planning, governance, risk management, budgeting, and operational problem solving.
Proficiency with Smartsheet and/or MS Project (Gantt), portfolio dashboards, and budget management tools; strong Excel/PowerPoint skills.
Exceptional written and verbal communication; comfort presenting to senior leadership.
- Familiarity with Medical Affairs planning cycles (insights, medical strategies, launch planning, metrics/KPIs).
- Process design/continuous improvement (templates, SOPs, training).
- Grants & IIS operations exposure (governance cadence, documentation, milestone tracking).
- Experience with publication planning governance and evidence generation planning cycles.
Requirements:
Start: asap
Duration: 12 months
Capacity: 5 days per week
Location: 3 days onsite in PA, 2 remote
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