Medical Writer with Clinical Focus

Job Summary

To support clinical evaluation efforts, the contract Medical Writer with Clinical Focus will work remotely, authoring Clinical Evaluation Reports (CERs) and conducting literature reviews to ensure compliance with Medical Device Regulation (MDR) requirements.

Key responsibilities

• Author sections of Clinical documentation for Clinical Evaluation Reports (CERs)
• Conduct comprehensive literature searches and critically appraise scientific literature
• Collaborate with internal teams to adhere to CER timelines and support regulatory activities

Required qualifications

• 2-4 years of medical writing experience, with a preference for experience in clinical evaluation report writing in the medical device industry
• Strong background in conducting literature searches and scientific data appraisal
• MD, PhD, or M.S. degree in a scientific field is desired
• Experience in protocol development and writing clinical sections for regulatory submissions
• Ability to manage multiple projects across various surgical disciplines