Medical Writer / Clinical Document Author

micro1; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

micro1 is seeking Medical Writers / Clinical Document Authors to participate in a customer project focused on developing AI-assisted writing tools for clinical documentation. In this remote contractor role, you will apply regulatory expertise to train AI systems and shape how models learn and perform.

You will author and review Clinical Study Reports and related documents, ensure ICH E3 alignment, and provide structured rationales to guide model improvements with real-world input.

Qualifications

• Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
• Experience independently authoring or leading the authoring of full Clinical Study Reports.
• 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.

Responsibilities

• Author and review 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.

Skills

Regulatory medical writing

ICH E3 knowledge

Clinical study report authoring

Strong written/verbal communication

Regulatory/clinical writing expertise

Education

Advanced degree in life sciences, pharmacy, or medicine

Job description

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. Originally posted on Himalayas