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 • Author and review evaluation tasks based on Clinical Study Reports and related regulatory documents • Assess document structure, sequencing, cross-referencing, and appendix organisation • Apply ICH E3 requirements and established regulatory-writing conventions • Review DSURs, PSURs/PBRERs, and other periodic safety documentation where relevant • Evaluate whether documentation meets expected clinical and regulatory standards Scientific Accuracy & Clinical Interpretation • Assess efficacy, safety, discussion, and conclusion sections for scientific accuracy • Distinguish substantive scientific errors from acceptable stylistic differences • Evaluate whether interpretations are supported by the underlying clinical evidence • Identify inconsistencies, overstatements, or unsupported conclusions • Apply expert judgement across varied clinical and therapeutic contexts Source Data & TFL Verification • Trace narrative claims to tables, figures, listings, protocols, and supporting records • Verify that clinical assertions are accurately grounded in source data • Identify discrepancies between narrative content and underlying TFLs • Review protocol requirements when assessing clinical-document accuracy • Document unsupported or incorrectly interpreted source information clearly AI Content Evaluation & Feedback • Review AI-generated clinical writing for accuracy, completeness, and structural compliance • Provide clear written rationales explaining evaluation decisions • Identify recurring model errors or areas requiring improved clinical reasoning • Distinguish content-quality issues from formatting or stylistic preferences • Deliver structured and actionable feedback supporting model improvement Evaluation Frameworks & Collaboration • Collaborate with project leads to refine clinical-writing evaluation frameworks • Help define best practices for AI-assisted regulatory documentation review • Contribute expertise across clinical phases and therapeutic areas • Support consistent evaluation standards across regulatory-writing tasks • Communicate complex clinical-document issues clearly to multidisciplinary stakeholders Ideal Profile • 5+ years of regulatory medical-writing 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, ICH E2C, and periodic safety documentation • Knowledge of eCTD structure and document placement • Demonstrated ability to interpret clinical protocols and TFLs • Strong experience verifying narrative claims against source data • Excellent written and verbal communication skills • Ability to provide structured, precise, and actionable clinical feedback • Advanced degree in life sciences, pharmacy, medicine, or a related field is highly valuable • Experience across multiple clinical phases and therapeutic areas is advantageous • Oncology and haematology expertise is especially valued • No prior AI-training or model-evaluation experience is required Engagement Details • Independent contractor engagement • Fully remote • Compensation: $30–$60/hour • Work will involve Clinical Study Report evaluation, regulatory medical writing, TFL analysis, protocol interpretation, scientific-accuracy review, and AI-assisted documentation assessment • Assignments may involve CSRs, DSURs, PSURs/PBRERs, clinical protocols, tables, figures, listings, and related regulatory materials • Strong ICH E3 knowledge and independent CSR-authoring experience are central to this engagement • Oncology and haematology experience is particularly valuable • Project scope, workload, document types, therapeutic areas, and evaluation standards may evolve depending on project requirements • 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. 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