Job Description
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.
* Provides HTA medical writing expertise for multiple compounds and/or projects, 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 appropriate guidance/direction from 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 type 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 elevation 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.
* Acts as interface to resolve issues and questions
* 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 appropriate guidance/direction from 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 type 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 elevation 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.
* Acts as interface to resolve issues and questions
* arising during the writing process. Works with manager throughout the document audit process and works with JCA Core team and manager 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.
Qualifications
* A minimum of 3+ years of bio-pharmaceutical industry experience in global pharma, biotech, life science, HTA agency organization delivering medicines/therapies to a broad market across various therapeutic areas.
* Extensive experience in writing HTA dossiers, eg AMNOG, HAS, NICE, CDA dossier preferred.
* Bachelor's Degree or higher in a scientific discipline.
* Outstanding written and oral communication skills, with a 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, biostatistics. Good understanding of regulatory requirements, and medical terminology cross functional teams and multiple contributors.
* Excellent English writing skills, 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.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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