Medical writer

• Lead the preparation, update, and quality control of Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER)
• Design and document systematic literature searches, appraise clinical evidence, and produce evidence synthesis
• Support PMCF planning and reporting, and where applicable, the SSCP
• Translate clinical and technical data into scientific manuscripts, research summaries, and white papers
• Act as the link between clinical, R&D, and regulatory teams, ensuring clinical evidence is reflected in documentation
• Establish project-specific style guidelines and maintain high quality standards

Freelance Medical Writer – Ophthalmology, AI-MDSW

• Execute consulting projects with a focus on developing market access and dossier strategies, including preparing related workshops and participating in oral hearings with relevant authorities
• Independently prepare benefit assessment dossiers for pharmaceuticals within the AMNOG process and for EU Health Technology Assessments (HTA) in collaboration with clients
• Perform scientific and statistical analysis, interpretation, gap analysis, and presentation of clinical study results
• Independently review scientific literature and prepare and document qualitative and quantitative analyses
• Collaborate in interdisciplinary, agile teams composed of clients and colleagues
• Apply state-of-the-art, AI-supported technological solutions and New Work methods (e.g., Design Thinking, SCRUM, Kanban)
• Actively contribute to the continuous development of Kintiga
• Receive targeted training and professional development in key market access disciplines.

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Freelance Medical Writer – Ophthalmology, AI-MDSW

Medical Writer