Remote Medical Writer for AI-Driven Clinical Docs

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

Job summary

micro1 is seeking a Medical Writer (Pharmaceutical) contractor to join a customer project focused on AI-assisted clinical documentation. You will apply your regulatory writing expertise to produce and review Clinical Study Reports and related documents.

Key requirements include at least 5 years of regulatory medical writing, experience authoring full CSRs, fluency with ICH E3 and eCTD placement, and strong written communication. Remote work is offered.

Qualifications

• Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
• Direct authoring experience leading 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.
• Able to read and interpret TFLs and protocol documents, identifying narrative divergences 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.
• Experience across multiple clinical phases; oncology and haematology expertise valued.

Responsibilities

• Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents for AI tool development.
• Apply expert judgment to assess AI-generated content against clinical template and structural requirements, including ICH E3 organization and appendix management.
• Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions.
• Trace narrative claims to source records to verify assertions are supported.
• Provide clear, structured written rationales for assessments to enable AI model improvements.
• Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in AI context.

Skills

Regulatory medical writing

Clinical document review

Structured feedback

Education

Advanced degree in life sciences, pharmacy, or medicine

Job description

micro1 is seeking a Medical Writer (Pharmaceutical) contractor to join a customer project focused on AI-assisted clinical documentation. You will apply your regulatory writing expertise to produce and review Clinical Study Reports and related documents.

Key requirements include at least 5 years of regulatory medical writing, experience authoring full CSRs, fluency with ICH E3 and eCTD placement, and strong written communication. Remote work is offered.