Freelance Medical Writer – Ophthalmology, AI-MDSW

This is a fully remote position, open to applicants in Germany.

📋 Description

• Oversee the creation, revision, and quality assurance of the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER).

• Design and document comprehensive literature searches, evaluate clinical evidence, and generate evidence synthesis.

• Assist in planning and reporting for Post-Market Clinical Follow-up (PMCF), and where applicable, the Summary of Safety and Clinical Performance (SSCP).

• Convert clinical and technical information into scientific manuscripts, research summaries, and white papers.

• Serve as the liaison between clinical, Research & Development (R&D), and regulatory teams to ensure clinical evidence is accurately represented in documentation.

• Develop project-specific style guidelines and uphold high-quality standards.

⛳️ Requirements

• Adequately qualified evaluator with expertise in diagnosing and managing the target indication.

• Dependable freelancer with a strong project management mindset.

• Proven experience in drafting and editing scientific manuscripts, abstracts, posters, and other clinical/scientific communications in English.

• Established track record (5+ years) in medical writing for medical devices, preferably Software as a Medical Device (SaMD) or Artificial Intelligence (AI).

• Capability to plan and carry out systematic literature searches, critically assess clinical data, and synthesize evidence.

• Practical experience in authoring and/or updating Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in compliance with Regulation (EU) 2017/745 (EU MDR).

🏝️ Benefits

• Collaboration on a project basis.

• Flexible, fully remote working environment.

• Opportunity for a long-term partnership on forthcoming clinical and regulatory projects.

• Startup culture with a fantastic, international team.

• High personal responsibility for your project and rapid personal development.

• Direct contribution to enhancing the quality of life for our end users (patients).