Working remotely on a full-time basis, the Medical Writer will create, research, edit, and coordinate the production of clinical documents for independent review while serving as the primary client contact for medical writing projects. Key responsibilities Gather, review, and finalize clinical documents for submission to regulatory authorities and other relevant stakeholders Manage document project timelines, coordinate interdepartmental reviews, and resolve project-related issues Ensure compliance with FDA/EMA guidelines and maintain high-quality standards in document preparation and editing Required qualifications Bachelor's Degree in a technical discipline (e.g., Science, Pharmacy, Nursing) or equivalent project-related experience Proven experience in clinical/scientific writing within regulated environments Solid knowledge of industry guidelines and regulations, such as ICH-GCP Experience with regulatory documents in a contract research organization, pharmaceutical, or biotechnology setting Fluency in English (written and verbal); proficiency in a non-English language is desirable
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