Principal Medical Writer leading CMC regulatory submissions for Veristat’s life - sciences clients. Authoring Modules 3 and 2.3 while guiding project teams and mentoring regulatory writers.
About the role
- Medical writer developing Clinical Study Reports and synthetic clinical trial data for 24-MAG’s remote consulting platform. Reviewing regulatory narratives, designing evaluation tasks, and ensuring scientific quality.
Responsibilities
- Draft complete, publication-quality sections of Clinical Study Reports
- Work across long-form clinical and regulatory documents requiring sustained consistency and technical accuracy
- Translate clinical trial data into clear, structured scientific narratives
- Ensure conclusions accurately reflect underlying study results
- Maintain consistency across tables, analyses, terminology, and narrative sections
- Review synthetic clinical trial datasets representing Phase I–III studies for accuracy, consistency, completeness, and plausibility
- Identify inconsistencies, unsupported conclusions, or missing information
- Validate whether written interpretations are appropriately supported by available data
- Contribute to the creation of high-quality synthetic clinical trial data
- Develop realistic study scenarios and data patterns grounded in clinical-development experience
- Evaluate generated datasets for internal consistency and clinical credibility
- Support quality-control processes for downstream research workflows
- Design sophisticated medical-writing assignments based on realistic clinical workflows
- Develop task instructions, expected deliverables, authoritative reference outputs, and objective evaluation criteria
- Assess clinical narratives and regulatory documents for scientific accuracy, clarity, structure, traceability, and internal consistency
- Identify fabricated, unsupported, or overstated claims and ensure appropriate professional judgement
Requirements
- 5+ years of professional medical-writing experience; 10–25 years preferred
- Extensive hands-on experience with pre-market Phase I–III clinical trial data
- Demonstrated experience authoring Clinical Study Reports (CSRs) and substantial sections of regulatory clinical documents
- Comfortable owning full-document and long-horizon writing assignments
- PhD or equivalent advanced academic/professional qualification
- Strong understanding of clinical-development workflows and study-data interpretation
- Ability to evaluate whether clinical conclusions are adequately supported by underlying evidence
- Exceptional scientific writing, editing, and quality-control skills
- Strong attention to detail across complex and lengthy documents
- Able to work independently and maintain consistency across multiple concurrent workflows
- Based in the United States, Canada, or France
- Minimum availability of approximately 20–25 hours per week
- Must not use confidential or proprietary information belonging to any employer, sponsor, client, institution, or other third party
- H1-B and STEM OPT support is unavailable for this engagement
Benefits
- Flexible scheduling based on project requirements
- Fully remote work
- Part-time independent contractor engagement
- Availability of 30+ hours per week preferred
- Projects may be extended, shortened, or concluded based on project needs and performance
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