Strategic Medical Writer

Allergan Aesthetics; Wiesbaden; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading biopharmaceutical company is seeking a Senior Medical Writer in Wiesbaden, Germany. The role involves producing high-quality HTA submissions and managing regulatory documentation processes. Candidates should have over 6 years of experience in the bio-pharmaceutical industry, expertise in HTA dossiers, and excellent communication skills. This position offers the opportunity to shape the medical writing capability within the organization.

Qualifikationen

• 6+ years in bio-pharmaceutical industry experience.
• Experience in writing HTA dossiers like AMNOG, HAS, NICE.
• Outstanding written and oral communication skills in English.

Aufgaben

• Write HTA dossier documents of various complexities.
• Serve as lead on clinical and regulatory documents.
• Coordinate review and approval processes for documents.

Kenntnisse

HTA dossier writing

Clinical research

Communication skills

Data analysis

Organizational skills

Ausbildung

Bachelor's Degree or higher in a scientific discipline

Jobbeschreibung

Overview

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, with expertise in HTA; oncology is a plus within a therapeutic area.

Responsibilities

• 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

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