Overview
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.
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.
* Able to write less complex document types (unmet need, disease burden sections) with little supervision; more complex documents require guidance and mentoring from senior writers and SMEs.
* Communicates JCA document deliverables, writing process, and timelines to team members and holds them accountable to agreed-upon project dates.
* Identifies and proposes solutions to resolve issues during the writing process, including escalation as appropriate; adheres to EU HTA conventions, grammar, and format requirements.
* Arranges and conducts review meetings with the team and acts as interface to resolve issues and questions; collaborates with the manager during document audits and with the JCA Core team to draft responses as necessary.
* Produces high-quality, compliant documents and ensures delivery within project timelines.
* Familiarity with HTA dossier regulations, requirements, and guidance associated with EU HTA regulations.
Qualifications
* Experience in the bio-pharmaceutical industry in global pharma, biotech, life science, or 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 preferred).
* Bachelor's Degree or higher in a scientific discipline.
* Outstanding written and oral communication skills with knowledge of medical 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 contributors.
* Excellent English writing skills to effectively communicate and influence complex scientific information to various stakeholders.
* Ability to collaborate with cross-functional teams and 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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