Strategic Medical Writer

Overview

Job Objective: The Medical Writer is responsible for providing clinical EUHTA document support to the JCA core team, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the clinical writing process.

Key Responsibilities

• Provides HTA medical writing expertise for multiple compounds and/or projects, with expertise in HTA; oncology is a plus within a therapeutic area.
• Interfaces with JCA core and extended teams (e.g., HTA Strategy, Access, DSS HTA Stats, VAC, HEOR S, Medical Affairs, Regulatory, Safety) to ensure accurate and timely completion/delivery of information and review of clinical EUHTA submissions.
• Assists with or implements activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated JCA documents.
• Understands, assimilates, and interprets sources of information with guidance from the JCA Core team and Senior Medical Writing mentor. Able to write less complex document types (unmet need, disease burden sections) with little supervision.
• Requires close supervision/mentoring on more complex document types and relies on review of subject matter experts and more senior writers for verification.
• Effectively communicates JCA document deliverables needed, writing process, and timelines to team members; holds team members accountable to agreed-upon project dates.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including escalation as appropriate.
• Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per EU HTA regulations and guidance materials.
• Arranges and conducts review meetings with the team and acts as interface to resolve issues and questions.
• Works with the manager throughout the document audit process and with the JCA Core team to draft responses as necessary.
• Produces and maintains focusing on quality and compliance and ensures delivery within project timelines.
• Familiarity with HTA dossier regulations, requirements and guidance associated with EU HTA regulations.
• Experience in the bio-pharmaceutical industry, including experience in global pharma, biotech, life science, and HTA agencies delivering medicines/therapies to a broad market across various therapeutic areas.
• Extensive experience in writing HTA dossiers (e.g., AMNOG, HAS, NICE, CDA dossier) is preferred.

Qualifications

• Bachelor\\\’s Degree or higher in a scientific discipline.
• Outstanding written and oral communication skills, with comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
• Proficient in assimilating and analyzing complex data.
• Advanced understanding of HTA dossiers and HTA requirements, clinical research, study designs, and biostatistics; good understanding of regulatory requirements and medical terminology across cross-functional teams and multiple contributors.
• Excellent English writing skills, with the ability to effectively communicate and influence complex scientific and medical information to various stakeholders.
• Ability to collaborate with cross-functional teams.
• Strong organizational, time management, and problem-solving skills.