Remote | Medical Writer / Clinical Document Author — $50–$80/hour at 24-MAG in New York, New York, United States

Job description

• We are sharing a specialised consulting opportunity for experienced Medical Writers and Clinical Document Authors with strong expertise in regulatory medical writing, Clinical Study Reports, ICH E3, periodic safety documentation, eCTD structure, TFL interpretation, and source-data verification to contribute to an advanced AI training and clinical-documentation evaluation project.
• Selected professionals will author and review clinical-document evaluation tasks, assess AI-generated regulatory content, verify narrative claims against source data, and provide structured feedback supporting AI-assisted clinical writing tools. No prior experience in AI is required.

Responsibilities

• Clinical & Regulatory Document Review
• Author and evaluate tasks based on Clinical Study Reports and related regulatory documents
• Review efficacy, safety, discussion, and conclusion sections for scientific accuracy and internal consistency
• Assess CSR structure, sequencing, appendices, and cross-referencing against ICH E3 expectations
• Review DSURs, PSURs/PBRERs, and related safety documentation using relevant ICH E2F and E2C conventions
• Evaluate eCTD structure and regulatory-document organisation where applicable
• Source Verification & Clinical Reasoning
• Trace narrative claims to protocols, tables, figures, listings, and other source materials
• Verify consistency between clinical narratives, endpoints, analysis populations, and statistical outputs
• Identify unsupported, overstated, or inconsistent conclusions
• Interpret TFLs and protocol-defined objectives using sound scientific judgement
• Distinguish substantive scientific issues from acceptable stylistic variation
• AI Evaluation & Quality Frameworks
• Review AI-generated clinical and regulatory writing for structural, scientific, and interpretive accuracy
• Diagnose weaknesses and provide clear written rationales for evaluation decisions
• Help define standards and best practices for high-quality regulatory writing
• Support reviewer calibration and refinement of evaluation frameworks
• Provide expert feedback supporting improvement of AI-assisted clinical documentation workflows

Requirements

• 5+ years of regulatory medical-writing experience
• Experience at a sponsor, CRO, or as an independent consultant
• Direct experience independently authoring or leading full Clinical Study Reports
• Strong working knowledge of ICH E3
• Familiarity with ICH E2F and ICH E2C safety-document conventions
• Working knowledge of eCTD structure and regulatory-document placement
• Strong ability to interpret protocols, tables, figures, and listings
• Demonstrated source-verification and scientific-accuracy assessment skills
• Excellent written communication, attention to detail, and regulatory judgement
• Advanced degree in life sciences, pharmacy, medicine, or a related field is highly valuable; equivalent regulatory-authoring experience may also be considered
• Experience across multiple clinical phases or therapeutic areas is advantageous
• Oncology and haematology expertise is especially valuable
• Familiarity with AI-assisted clinical documentation tools is beneficial but not required
• No prior AI-training or model-evaluation experience is required

Skills

Required

• Regulatory medical writing
• Clinical document authoring
• ICH E3 knowledge
• ICH E2F and ICH E2C familiarity
• eCTD structure knowledge
• Protocol interpretation
• TFL interpretation
• Source-data verification
• Scientific accuracy assessment
• Written communication
• Attention to detail
• Regulatory judgement

Preferred

• Oncology and haematology expertise