Remote - Medical Writer; Pharmaceutical

About the job Remote | Medical Writer (Pharmaceutical) - $30-$60/hour

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.

• 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

• 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

• 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

• 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

• 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

• 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

• 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…