[Hiring] Medical Writer @24-MAG

Role Description

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

Qualifications

• 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. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams.

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