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Freelance Medical Writer – Ophthalmology, AI-MDSW
deepeye MedicalFreelance Medical Writer developing clinical evaluation documents for an AI-driven ophthalmology software startup. Leading clinical evidence synthesis and collaborating across teams in a fully remote role.
Core Competencies
Role fitCore Competencies
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Demonstrates expertise in medical writing, particularly in drafting Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for medical devices, with a strong focus on systematic literature searches and evidence synthesis. Proven ability to translate complex clinical data into clear scientific communications while maintaining high quality standards.
Highest-signal resume keywords
Clinical Evaluation Plan (CEP) AuthoringClinical Evaluation Report (CER) AuthoringSystematic Literature Search PlanningMedical Writing for Medical DevicesRegulation (EU) 2017/745 (EU MDR) Compliance
ATS Keywords
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Hard Skills
Clinical Evaluation Plan (CEP) AuthoringClinical Evaluation Report (CER) AuthoringSystematic Literature SearchEvidence SynthesisScientific Manuscript DraftingClinical Data AppraisalProject ManagementMedical WritingEditing Scientific CommunicationsRegulatory Documentation
Soft Skills
Reliable Freelancer MindsetStrong Project Management
Industry Keywords
Medical DevicesSaMDAIClinical EvidenceScientific CommunicationsQuality ControlClinical EvaluationPost-Market Clinical Follow-up (PMCF)Clinical Evidence SynthesisRegulatory Teams Collaboration
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- Suitably qualified evaluator with expertise in the diagnosis and management of the target indication
- Reliable freelancer mindset with strong project management
- Demonstrated experience drafting and editing scientific manuscripts/abstracts/posters and other clinical/scientific communications in English
- Proven track record (5+ years) in medical writing for medical devices (ideally SaMD/AI)
- Ability to plan and execute systematic literature searches, critically appraise clinical data, and synthesize evidence
- Hands-on experience authoring and/or updating Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance with Regulation (EU) 2017/745 (EU MDR)
Benefits
Comp & perks- Project-based collaboration
- Flexible, fully remote setup
- Potential for long-term partnership on upcoming clinical and regulatory projects
- Startup culture & a great, international team
- High personal responsibility for your project & fast personal growth
- Direct impact on improving quality of life for our end users (patients)