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Director, Market Access, Health Technology Assessment Ops – Hematology(m/w/x)
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
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Word
- Excel
- MS Project
- MS PowerPoint
- Outlook
Noch nicht perfekt?
- BeOne Medicines I GmbHVollzeitnur vor OrtSeniorBasel
- BeOne Medicines I GmbH
Director, Global Value, Access & Pricing, Solid Tumors, Pipeline(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Access Strategy Leader - Oncology(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Abbott Products Operations AG
Global Market Access Lead Biologics(m/w/x)
Vollzeitnur vor OrtSeniorAllschwil - Novartis
Dir, Access International(m/w/x)
Vollzeitnur vor OrtSeniorBasel
Director, Market Access, Health Technology Assessment Ops – Hematology(m/w/x)
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
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Word
- Excel
- MS Project
- MS PowerPoint
- Outlook
Über das Unternehmen
BeOne Medicines I GmbH
Branche
Healthcare
Beschreibung
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Noch nicht perfekt?
- BeOne Medicines I GmbH
Associate Director, Market Access, Europe(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines I GmbH
Director, Global Value, Access & Pricing, Solid Tumors, Pipeline(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Access Strategy Leader - Oncology(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Abbott Products Operations AG
Global Market Access Lead Biologics(m/w/x)
Vollzeitnur vor OrtSeniorAllschwil - Novartis
Dir, Access International(m/w/x)
Vollzeitnur vor OrtSeniorBasel