Medical Writer
Core
Author and review realistic evaluation tasks based on Clinical Study Reports and regulatory documents to train AI-assisted writing tools for clinical documentation.
Role type
Senior IC medical writer (regulatory/clinical)
Builds
AI training datasets and evaluation frameworks for clinical documentation tools
Domain
Life Sciences / Clinical Regulatory Writing / AI
Deliverable
production ML models
Required skills
Clinical Study Report authoring, ICH E3 compliance, periodic safety documentation (ICH E2F, E2C), eCTD placement, TFL interpretation, scientific accuracy assessment, source data tracing
Preferred skills
Oncology and haematology expertise, multi-phase clinical experience, independent leadership of full reports
Technologies
eCTD, ICH E3, ICH E2F, ICH E2C
Responsibilities
Author and review evaluation tasks for AI training, assess AI-generated content against clinical templates, evaluate scientific accuracy in narrative sections, trace claims to source records, provide structured rationales for assessments, collaborate on evaluation frameworks
Seniority
Senior, hands-on IC
