Job Description
* Reports to Global HTA Director
* Based hybrid working in Maidenhead, UK office
* Excellent opportunities for career progression
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, 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 mentorAble 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 appropriateUnderstands/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
* Experience in 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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