Strategic Medical Writer

The HTA 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 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 Strategy Medical Affairs Regulatory Safety) to ensure accurate and timely completion/delivery of information and review of EUHTA submissions.

Responsibilities:

• 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.
• Bachelors 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.

US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time

Key Skills
Clinical Research,Adobe Acrobat,FDA Regulations,Technical Writing,Biotechnology,Clinical Development,Clinical Trials,Microsoft Powerpoint,Research Experience,Document Management Systems,Word Processing,Writing Skills
Experience: years
Vacancy: 1