Strategic Medical Writer

AbbVie Inc; Wiesbaden; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

A global biopharmaceutical company is seeking an HTA Writer in Wiesbaden, Germany. The role focuses on providing clinical EUHTA document support, ensuring high-quality submissions, and interfacing with multiple teams. Candidates should have over 3 years of experience in the pharmaceutical industry, particularly in writing HTA dossiers. Strong communication skills and the ability to collaborate effectively are essential. This position offers a chance to contribute to innovative medicine and improve patient outcomes.

Qualifikationen

• 3+ years in bio-pharmaceutical industry experience.
• Expertise in writing HTA dossiers (AMNOG, HAS, NICE preferred).
• Outstanding written and oral communication skills.

Aufgaben

• Write less complex documents with little supervision.
• Conduct review meetings with the team.
• Ensure delivery within project timelines.

Kenntnisse

Clinical writing

Cross-functional collaboration

Problem-solving

Time management

Ausbildung

Bachelor's Degree in scientific discipline

Jobbeschreibung

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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.
• 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.

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