Associate Director, JCA Dossier Content (EU HTA)

Overview

As Associate Director, JCA Dossier Content, you drive the preparation of product-specific JCA dossiers under EU HTA regulations. You collaborate with regional and global teams to align dossier content with the value strategy and regulatory requirements. You lead content development, ensure timely delivery, and oversee literature reviews and synthesis of evidence. You play a pivotal role in cross-functional coordination to support market access across Europe, ensuring high-quality, compliant dossiers.

Responsibilities

• Lead writing of product-specific JCA Dossiers aligned with the product value strategy
• Ensure timely development of required JCA Dossier sections
• Collaborate with EU HTA Dossier Lead to secure timely task execution
• Input strategic options related to dossier content
• Coordinate with cross-functional teams to ensure timely and translatable content
• Coordinate with RDMA to inform country medical teams about the dossier
• Conduct comprehensive literature searches to support content generation
• Stay updated on JCA process and rules
• Ensure compliance with EU HTAR standards
• Oversee SLR and integration of outputs into the dossier
• Leverage digital tools to streamline dossier creation and maintenance

Key requirements

• Minimum 5 years experience as an HTA or Medical Writer in pharma
• Experience writing large, complex documents and dossiers in English
• Ability to integrate complex clinical, statistical, and methodological evidence
• Strong working knowledge of oncology
• Experience in Regional or Global roles or collaborating with regional/global teams
• MS degree in Life Sciences or related field

• Cross-functional collaboration
• Regulatory writing
• Scientific writing
• HTA
• Medical Writing
• Oncology

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