DEPARTMENT FUNCTION AND OBJECTIVE

The local Medical Affairs Evidence Generation function is responsible for translating approved evidence priorities into high-quality, compliant studies and scientific publications. The function delivers affiliate evidence plans through disciplined study execution, effective external-partner management, robust portfolio oversight, and timely dissemination of evidence across relevant internal and external scientific channels.

PRIMARY FUNCTION

Lead end-to-end execution of approved evidence-generation studies and scientific publications through effective management of CROs, vendors, investigators, timelines, budgets, and scientific dissemination activities.

Reporting to the Evidence Generation Lead, the Evidence Generation Specialist / Advisor is responsible for operational delivery of the affiliate evidence-generation portfolio, including study planning and execution, site and investigator coordination, vendor governance, publication planning, documentation quality, inspection readiness, and performance reporting.

The role collaborates with Medical, Market Access, Commercial, Regulatory, Finance, Legal, Clinical Operations, and other relevant functions to support compliant and impactful generation and dissemination of scientific evidence.

MAJOR DUTIES AND RESPONSIBILITIES

Study Execution Excellence

• Lead execution of all approved evidence-generation studies.
• Develop detailed implementation plans with clear timelines, milestones, budgets, and forecasts.
• Monitor study progress, risks, and mitigation actions throughout execution.
• Maintain study master files and ensure complete, compliant, and inspection-ready documentation.
• Support study-related audits and inspections as required.

CRO & Vendor Management

• Act as the primary contact for all CRO partners.
• Manage vendor selection and onboarding.
• Monitor vendor performance against defined KPIs.
• Conduct governance meetings with CROs.
• Review deliverables and quality outputs.
• Monitor contracts, purchase orders, and financial reconciliation.

Site & Investigator Management

• Coordinate investigator engagement activities.
• Support site identification and activation.
• Facilitate study start-up activities.
• Resolve operational study challenges.
• Coordinate study close-out processes.

Evidence Generation Portfolio Monitoring

• Track recruitment and overall study progress.
• Identify timeline or budget risks.
• Escalate critical issues to the Evidence Generation Lead and/or Medical Director.
• Provide monthly study-health updates.

Publication Lead Responsibilities

• Own affiliate publication planning.
• Lead publication strategy execution.
• Manage publication vendors and medical writers.
• Coordinate manuscript and abstract development and submission.
• Ensure publication compliance and required approvals.
• Secure required approvals for encore presentations of headquarters posters.

Scientific Communication

• Coordinate evidence dissemination activities across Medical, Market Access, and Commercial teams.
• Maintain publication trackers, budgets, and impact metrics, including usage across Medical, Commercial, and Market Access teams.