Clinical Trial & Regulatory Medical Writer

This is a fully remote position, open to applicants in United States, +3 more locations.

📋 Description

• Prepare comprehensive, publication-ready sections of Clinical Study Reports.

• Collaborate on lengthy clinical and regulatory documents that require continuous consistency and technical precision.

• Convert clinical trial data into coherent, structured scientific narratives.

• Ensure that conclusions accurately represent the underlying study findings.

• Maintain uniformity across tables, analyses, terminology, and narrative segments.

• Review synthetic clinical trial datasets from Phase I–III studies for accuracy, consistency, completeness, and plausibility.

• Detect inconsistencies, unsupported conclusions, or absent information.

• Confirm that written interpretations are appropriately substantiated by available data.

• Aid in the development of high-quality synthetic clinical trial data.

• Create realistic study scenarios and data patterns based on clinical-development experience.

• Assess generated datasets for internal consistency and clinical viability.

• Assist in quality-control processes for subsequent research workflows.

• Design intricate medical-writing projects grounded in realistic clinical workflows.

• Create task instructions, anticipated deliverables, authoritative reference outputs, and objective evaluation criteria.

• Evaluate clinical narratives and regulatory documents for scientific accuracy, clarity, structure, traceability, and internal consistency.

• Identify fabricated, unsupported, or exaggerated claims and ensure appropriate professional judgment is applied.

⛳️ Requirements

• A minimum of 5 years of professional medical-writing experience; 10–25 years preferred.

• Extensive practical experience with pre-market Phase I–III clinical trial data.

• Proven experience in authoring Clinical Study Reports (CSRs) and substantial sections of regulatory clinical documents.

• Comfortable managing full-document and long-term writing assignments.

• PhD or equivalent advanced academic/professional credentials.

• Strong knowledge of clinical-development workflows and study-data interpretation.

• Ability to assess whether clinical conclusions are sufficiently supported by underlying evidence.

• Exceptional skills in scientific writing, editing, and quality control.

• Keen attention to detail across complex and lengthy documents.

• Capable of working independently while ensuring consistency across multiple concurrent workflows.

• Must be based in the United States, Canada, or France.

• Minimum availability of approximately 20–25 hours per week.

• Must refrain from using confidential or proprietary information belonging to any employer, sponsor, client, institution, or other third party.

• H1-B and STEM OPT support is not available for this engagement.

🏝️ Benefits

• Flexible scheduling based on project requirements.

• Fully remote work.

• Part-time independent contractor engagement.

• Preference for availability of 30+ hours per week.

• Project duration may be extended, shortened, or concluded based on project needs and performance.