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. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams.
By submitting this application, you acknowledge that your information may be processed by 24-MAG LLC for recruitment and opportunity matching in accordance with our Privacy Policy: https://www.24-mag.com/privacy-policy