Senior Strategic Medical Writer

Wiesbaden, HE

• Function: Commercial
• Job Type: Full-time

Job ID: R00133444
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.
Job Description
The Senior 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. The Senior Medical Writer will help to establish the new capability (eg medical writing) for IMAP.
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.
The Senior 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. The Senior Medical Writer will help to establish the new capability (eg medical writing) for IMAP.
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.

• Demonstrated capability to write all HTA dossier document types in remit, regardless of complexity.
• Independently writes highly complex clinical JCA submissions documents and dossier components including but not limited to Sections, Appendices of JCA dossier, Health Authorities (HA) responses, and summary documents, support development of PICO, MAAP and Post Hoc analysis requests.
• Serves as a lead on JCA clinical and regulatory dossier documents and documents such as those associated with agency interactions.
• Functions with a high degree of autonomy on draft materials, but relies on review of subject matter experts. Develops knowledge and contributes to understanding of submission strategy development.
• Coordinates the review, approval, and quality control of other functions involved in the production of clinical and regulatory projects.
• Manages and supervises Vendor Medical Writing team.
• Arranges and conducts review meetings with the team.
• Produces and maintains clinical documents focusing on quality and compliance and ensures delivery within project timelines. Develops understanding of project management concepts and accepts greater responsibility for driving submission objectives.
• Helps to establish medical writing capability within IMAP through the support of process and governance development.
• Develops knowledge of JCA and international regulations, requirements, and guidelines pertaining to the preparation of JCA documentation. Guidance associated with preparation of JCA documentation.
• Participates in execution of tactical process improvements.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.

Qualifications

• A minimum of 6 + 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.htm

Please refer the Job description for details