We are sharing a specialised consulting opportunity for experienced Medical Writers with strong expertise in regulatory medical writing, Clinical Study Report authoring, ICH guidelines, scientific accuracy assessment, source-data verification, and clinical-document evaluation to contribute to an advanced AI training and clinical-writing project.
Selected professionals will author and review realistic evaluation tasks based on clinical and regulatory documents, assess AI-generated content for structural and scientific accuracy, trace narrative claims to source data, and provide structured feedback grounded in professional medical-writing standards. No prior experience in AI is required.
Key Responsibilities
Clinical & Regulatory Document Review
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Author and review evaluation tasks based on Clinical Study Reports and related regulatory documents
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Assess document structure, sequencing, cross-referencing, and appendix organisation
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Apply ICH E3 requirements and established regulatory-writing conventions
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Review DSURs, PSURs/PBRERs, and other periodic safety documentation where relevant
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Evaluate whether documentation meets expected clinical and regulatory standards
Scientific Accuracy & Clinical Interpretation
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Assess efficacy, safety, discussion, and conclusion sections for scientific accuracy
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Distinguish substantive scientific errors from acceptable stylistic differences
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Evaluate whether interpretations are supported by the underlying clinical evidence
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Identify inconsistencies, overstatements, or unsupported conclusions
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Apply expert judgement across varied clinical and therapeutic contexts
Source Data & TFL Verification
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Trace narrative claims to tables, figures, listings, protocols, and supporting records
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Verify that clinical assertions are accurately grounded in source data
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Identify discrepancies between narrative content and underlying TFLs
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Review protocol requirements when assessing clinical-document accuracy
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Document unsupported or incorrectly interpreted source information clearly
AI Content Evaluation & Feedback
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Review AI-generated clinical writing for accuracy, completeness, and structural compliance
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Provide clear written rationales explaining evaluation decisions
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Identify recurring model errors or areas requiring improved clinical reasoning
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Distinguish content-quality issues from formatting or stylistic preferences
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Deliver structured and actionable feedback supporting model improvement
Evaluation Frameworks & Collaboration
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Collaborate with project leads to refine clinical-writing evaluation frameworks
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Help define best practices for AI-assisted regulatory documentation review
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Contribute expertise across clinical phases and therapeutic areas
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Support consistent evaluation standards across regulatory-writing tasks
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Communicate complex clinical-document issues clearly to multidisciplinary stakeholders
Ideal Profile
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5+ years of regulatory medical-writing experience at a sponsor, CRO, or as an independent consultant
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Direct experience independently authoring or leading full Clinical Study Reports
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Strong working knowledge of ICH E3
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Familiarity with ICH E2F, ICH E2C, and periodic safety documentation
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Knowledge of eCTD structure and document placement
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Demonstrated ability to interpret clinical protocols and TFLs
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Strong experience verifying narrative claims against source data
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Excellent written and verbal communication skills
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Ability to provide structured, precise, and actionable clinical feedback
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Advanced degree in life sciences, pharmacy, medicine, or a related field is highly valuable
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Experience across multiple clinical phases and therapeutic areas is advantageous
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Oncology and haematology expertise is especially valued
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No prior AI-training or model-evaluation experience is required
Engagement Details
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Independent contractor engagement
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Fully remote
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Compensation: $30–$60/hour
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Work will involve Clinical Study Report evaluation, regulatory medical writing, TFL analysis, protocol interpretation, scientific-accuracy review, and AI-assisted documentation assessment
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Assignments may involve CSRs, DSURs, PSURs/PBRERs, clinical protocols, tables, figures, listings, and related regulatory materials
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Strong ICH E3 knowledge and independent CSR-authoring experience are central to this engagement
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Oncology and haematology experience is particularly valuable
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Project scope, workload, document types, therapeutic areas, and evaluation standards may evolve depending on project requirements
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Work must be completed without using confidential, proprietary, patient-identifiable, or unpublished clinical information belonging to any employer, sponsor, CRO, healthcare organisation, institution, 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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