Evidence Generation Specialist

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. 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.

• 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

• 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

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

• 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

• 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

• 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

Bachelor's degree in Medicine, Pharmacy, Clinical Pharmacy, Life Sciences, Public Health, Healthcare Sciences, or a related healthcare discipline. Advanced degree (Master's) in Clinical Research, Epidemiology, Public Health, Health Economics, or a related field is a plus.

Minimum 3 years of relevant experience in Clinical Research Operations and/or Evidence Generation. Demonstrated experience in study start-up, execution, monitoring, close-out, vendor management, investigator/site engagement, and budget tracking. Experience in one or more of the following roles:
Clinical Research Coordinator (CRC) Clinical Research Associate (CRA) Clinical Project Lead (CPL) Real-World Evidence (RWE) Lead Clinical Operations, Study Management, or Research Management roles within pharmaceutical companies, CROs, hospitals, or research institutions.

Good understanding of:
Clinical research methodologies and study management. Real-World Evidence (RWE), observational studies, registries, and non-interventional research. ICH-GCP principles, SFDA regulations, ethics committee requirements, and audit readiness. Scientific publications, abstracts, posters, and manuscript development.

Experience in research question ideation, evidence-gap identification, and development of evidence-generation strategies. Experience in concept sheet development, protocol writing, protocol review, and study design. Ability to translate scientific and clinical questions…