Strategic Medical Writer

Allergan; Wiesbaden; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A global biopharmaceutical company in Wiesbaden is seeking an experienced HTA Writer to provide clinical document support. The role requires expertise in writing HTA dossiers and a minimum of three years in the bio-pharmaceutical industry. Responsibilities include producing submission-ready documents and collaborating with various teams to ensure the timely completion of project deliverables. Outstanding written and oral communication skills are essential, along with proficiency in analyzing complex data.

Qualifikationen

• 3+ years of experience in bio-pharmaceutical or HTA agency organizations.
• Extensive experience in writing HTA dossiers preferred.
• Advanced understanding of HTA dossiers and clinical research.

Aufgaben

• Write less complex document types with little supervision.
• Communicate document deliverables and timelines to team members.
• Conduct review meetings and resolve issues during writing.

Kenntnisse

HTA writing expertise

Outstanding written and oral communication skills

Proficient in assimilating and analyzing complex data

Strong organizational skills

Problem-solving skills

Ausbildung

Bachelor's Degree or higher in a 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 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.