Medical Writer / Clinical Document Author

Medicine & Health • Remote • via micro1

This role is hiring through micro1, not NeonLabs. The description below is micro1’s own wording from their official listing, so "we" and "our" refer to micro1.

About this role

Role Title: Medical Writer / Clinical Document Author

Role Type: Contractor

Location: Remote

micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer’s project focused on developing advanced AI-assisted writing tools for clinical documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required , your domain knowledge is what matters.

Scope of Work

• Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
• Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
• Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
• Trace narrative claims to source records, tables, figures, listings, and protocols, to verify that all assertions are appropriately supported.
• Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.
• Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.

Preferred Qualifications

• Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
• Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
• Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
• Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
• Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
• Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
• Experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise is especially valued.

Join our customer's team and leverage your authoring expertise to help design the next generation of AI-assisted clinical documentation solutions. This high-bar role offers you the chance to shape how tomorrow's writing teams draft and review regulatory documents , through your expert input, judgment, and real-world experience.

Key skills

• regulatory medical writing
• clinical study report authoring
• ich e3 guidelines
• scientific accuracy assessment
• source data verification
• clinical protocol interpretation
• tfl (tables, figures, listings) analysis
• written communication
• structured feedback provision
• collaborative problem-solving
• ai-assisted documentation evaluation
• periodic safety documentation (ich e2f, ich e2c)
• ectd (electronic common technical document) knowledge
• oncology and haematology domain expertise

Details

• Company: micro1
• Location: Remote
• Eligible locations: Bangladesh, Hong Kong, India, Indonesia, Japan, Kazakhstan and 52 more
• Platform: micro1

Apply directly through micro1 using the link below. micro1 hires experts for remote, flexible roles training and evaluating frontier AI systems.