Associate Director, JCA Dossier Content (EU HTA)
Core
Develop and write product-specific Joint Clinical Assessment (JCA) Dossiers for the EU Health Technology Assessment (HTA) process, ensuring alignment with value strategy and regulatory requirements.
Role type
Senior Medical Writer / HTA Specialist (Oncology)
Builds
Product-specific JCA Dossiers for EU markets
Domain
Life Sciences / Oncology / Health Technology Assessment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HTA dossier writing, Medical writing, Oncology domain expertise, Systematic literature review (SLR), Regulatory compliance, Cross-functional collaboration, Strategic content alignment, Evidence integration, Template adherence, Regional/global team coordination
Preferred skills
In-house pharmaceutical experience, Large complex document authoring, English proficiency, Regional/Global role experience
Technologies
Digital solutions for dossier creation and maintenance
Responsibilities
Lead writing of product-specific JCA Dossiers, Conduct comprehensive literature searches, Ensure accuracy and regulatory compliance of dossier content, Coordinate SLR with contributing functions, Align dossier content with value strategy, Represent the team in regional JCA Dossier generation teams
Seniority
Senior, hands-on IC