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BEBeOne Medicines I GmbH

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

Basel
Full-timeOn-siteSenior

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.

Requirements

  • 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%

Tasks

  • 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

Work Experience

  • 7 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • Microsoft Word
  • Excel
  • MS Project
  • MS PowerPoint
  • Outlook
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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