Job Details

About the job Remote | Medical Writer / Clinical Document Author - $50-$80/hour

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 realistic clinical-document evaluation tasks, assess AI-generated regulatory content for scientific and structural accuracy, trace narrative claims back to source data, and provide clear written rationales that support improvement of AI-assisted clinical writing tools. The work requires substantial hands-on regulatory authoring experience and strong judgement across clinical and safety documentation. No prior experience in AI is required.

Key Responsibilities

Clinical Study Report Evaluation

• Author and review evaluation tasks based on Clinical Study Reports
• Assess whether generated content follows appropriate clinical-document conventions
• Review efficacy, safety, discussion, and conclusion sections for scientific accuracy
• Identify missing, unsupported, or internally inconsistent statements
• Distinguish substantive scientific issues from acceptable stylistic variation

ICH E3 Structure & Document Quality

• Assess Clinical Study Reports against ICH E3 expectations
• Review document organisation, sequencing, and section completeness
• Evaluate cross-referencing between sections and supporting materials
• Review appendix structure and document-management consistency
• Identify structural deficiencies affecting regulatory usability

Source Data Verification

• Trace narrative claims to underlying tables, figures, listings, and protocols
• Verify that clinical statements are supported by source data
• Identify discrepancies between narrative interpretation and statistical outputs
• Assess whether reported findings accurately reflect available evidence
• Document unsupported or overstated conclusions clearly

TFL & Protocol Interpretation

• Review tables, figures, and listings supporting clinical narratives
• Interpret protocol-defined objectives, endpoints, and analysis requirements
• Evaluate consistency between protocols, TFLs, and written conclusions
• Identify population, endpoint, or interpretation mismatches
• Apply strong scientific judgement when reviewing complex clinical evidence

Periodic Safety Documentation

• Review content derived from DSURs, PSURs, and PBRERs
• Apply familiarity with ICH E2F and ICH E2C conventions
• Evaluate safety narratives and aggregate reporting for accuracy
• Assess consistency between safety documentation and supporting evidence
• Identify gaps or errors affecting regulatory interpretation

Scientific Accuracy & Clinical Reasoning

• Evaluate the scientific defensibility of clinical narratives
• Identify factual, interpretive, or contextual errors
• Distinguish genuine scientific problems from differences in writing style
• Review clinical conclusions for proportionality to underlying evidence
• Apply therapeutic-area expertise where relevant

AI-Assisted Documentation Evaluation

• Review AI-generated clinical and regulatory writing
• Diagnose structural, scientific, and interpretive weaknesses
• Provide clear written rationales explaining evaluation decisions
• Support refinement of AI-assisted clinical documentation workflows
• Contribute expert feedback to improve model behaviour and output quality

Evaluation Framework & Best-Practice Development

• Collaborate with project leads to improve evaluation frameworks
• Help define standards for high-quality regulatory clinical writing
• Document best practices for assessing AI-generated clinical content
• Support calibration across reviewers and evaluation tasks
• Contribute domain expertise to evolving quality criteria

Ideal Profile

• Minimum 5 years of regulatory medical-writing experience
• Experience working 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 periodic safety-document conventions
• Working knowledge of eCTD placement and regulatory-document structure
• Demonstrated ability to interpret clinical protocols
• Strong ability to read and analyse tables, figures, and listings
• Experience identifying discrepancies between narrative content and source data
• Strong scientific accuracy assessment and source-verification skills
• Excellent written and verbal communication ability
• Strong attention to detail and regulatory judgement
• Ability to provide structured and actionable written feedback
• Advanced degree in life sciences, pharmacy, medicine, or a related field is highly valuable
• Equivalent depth of regulatory authoring experience may also be considered
• Experience across multiple clinical phases and 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

Engagement Details

• Independent contractor engagement
• Fully remote
• Compensation: $50-$80/hour
• Work will involve regulatory medical writing, CSR evaluation, ICH E3 review, TFL interpretation, protocol analysis, source-data verification, periodic safety documentation, and AI-assisted content evaluation
• Strong hands-on Clinical Study Report authoring experience is central to this engagement
• Assignments may involve CSRs, DSURs, PSURs/PBRERs, protocols, TFLs, eCTD materials, and AI-generated regulatory content
• Oncology and haematology expertise may be particularly valuable for some assignments
• Collaboration will occur remotely with project leads and other subject-matter experts
• Project scope, workload, therapeutic areas, and evaluation standards may evolve depending on project requirements
• Work must be completed without using confidential, proprietary, or identifiable patient information belonging to any employer, sponsor, CRO, healthcare organisation, research institution, patient, or other third party

About the Platform

This opportunity is available through 24-MAG LLC. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams.

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