Beschreibung

In this role, you will coordinate and manage the operational activities for EU HTA processes, ensuring timely execution and high-quality contributions from cross-functional teams. Day-to-day responsibilities include leading project timelines, facilitating collaboration, and driving continuous improvement in a dynamic environment.

Anforderungen

• •Master’s degree
• •Advanced degree (PharmD, MD, PhD) in scientific, medical, or health economics discipline
• •Efficiency in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook
• •Master's degree with minimum 7+ years of experience in market access, evidence generation, or regulatory affairs within pharmaceutical/biotech industry, or 5+ years of experience with PharmD, MD, PhD
• •Proven experience leading cross-functional projects
• •Strong project management and organizational capabilities
• •Oncology experience
• •Excellent interpersonal and communication skills
• •Strong scientific & medical literacy
• •Solid understanding of EU HTA Regulation (EU 2021/2282), JCA dossier templates, JSC processes, and Implementing Acts
• •Experience working with third-party vendors
• •Ability to work independently and handle multiple priorities
• •Fluency in English (written and verbal)
• •Limited travel may be required, up to 10%

Aufgaben

• •Manage operational activities for EU HTA JCA and JSC processes
• •Coordinate global, regional, and country contributors
• •Manage project timelines and ensure consistent evidence inputs
• •Lead meeting operations and support submissions via the EU HTA IT platform
• •Facilitate internal alignment and vendor management
• •Collaborate with the EU HTA Coordination Group during JCA/JSC interactions
• •Shape internal operational processes and build organizational capability
• •Drive development of JCA dossier strategy with cross-functional teams
• •Oversee day-to-day operations for the JCA dossier team
• •Manage SharePoint, schedule meetings, draft agendas, and track actions
• •Coordinate cross-functional inputs for timely JCA strategy contributions
• •Incorporate PICO simulation and feasibility assessments into JCA planning
• •Oversee evidence retrieval activities for dossier integration
• •Coordinate epidemiology data collection across EEA markets
• •Manage dossier uploads and submissions via the EU HTA IT platform
• •Support internal horizon scanning for JSC feasibility assessments
• •Coordinate JSC operational activities and documentation tracking
• •Engage SMEs to ensure readiness and consistent evidence positions
• •Develop and maintain comprehensive project timelines for JCA and JSC
• •Align JCA and JSC timelines with regulatory milestones
• •Collaborate with HEOR on PICO simulation and information retrieval
• •Ensure timely delivery of cross-functional contributions
• •Identify key risks and propose mitigation strategies
• •Drive continuous improvement and optimize internal workflows
• •Support development of training materials for EU HTA readiness
• •Promote knowledge management and dissemination of best practices

Tools & Technologien