Micro1 review · AI Training & Data Labeling
Medical Writer (Pharmaceutical) — AI Clinical Writing Evaluation (micro1)
What the work involves
micro1 is engaging Medical Writers and Clinical Document Authors on a customer project to develop advanced AI-assisted writing tools for clinical documentation. You'll author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs and related documents, then apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements — ICH E3 organization, section sequencing, cross-referencing and appendix management.
You'll also evaluate scientific accuracy in narrative sections (efficacy, safety summaries, discussion, conclusions), distinguishing true scientific or interpretive errors from stylistic differences; trace narrative claims back to source records — tables, figures, listings and protocols — and write clear, structured rationales that let the team precisely diagnose and improve model behavior. No prior AI experience is required — your domain authoring expertise is what matters.
What you'll do
- Author and review realistic evaluation tasks from CSRs, DSURs, PSURs/PBRERs and related clinical documents
- Assess whether AI-generated content meets ICH E3 structure: section sequencing, cross-referencing, appendix management
- Evaluate scientific accuracy in efficacy, safety, discussion and conclusions narratives
- Trace narrative claims to source tables, figures, listings and protocols
- Provide clear, structured written rationales for each assessment
- Collaborate with project leads to refine evaluation frameworks and document best practices
Requirements & eligibility
- Minimum 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, beyond summaries or partial contributions
- Fluency with ICH E3 and periodic safety documentation conventions (ICH E2F, ICH E2C) and eCTD placement
- Ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data
- Exceptional written and verbal communication, with structured, actionable feedback on clinical content
- Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience
- Preferred: experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise especially valued
How to apply
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