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BEBeOne Medicines I GmbH

Director, Market Access, Health Technology Assessment Ops – Hematology(m/w/x)

Basel
VollzeitVor OrtSenior

Managing EU HTA JCA/JSC operational activities for hematology products, coordinating global contributors at a cancer-focused biotech. 7+ years in evidence generation or regulatory affairs within pharma/biotech, with cross-functional project leadership, required. Global coordination across regions, supporting submissions via EU HTA IT platform.

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

Berufserfahrung

  • 7 Jahre

Ausbildung

  • Master-Abschluss

Sprachen

  • Englischverhandlungssicher

Tools & Technologien

  • Microsoft Word
  • Excel
  • MS Project
  • MS PowerPoint
  • Outlook
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