Remote Medical Writer / Clinical Document Author

vmysmartpros; India; Remote; INR 6,579,000 - 10,526,000; Full time

Job summary

micro1 is seeking a Medical Writer / Clinical Document Author for remote contract work to support AI-assisted clinical documentation. You will apply your expertise to develop evaluation tasks for Clinical Study Reports and related regulatory documents, ensuring accuracy and proper structure. Training AI models depends on your real-world input and judgment.

The role emphasizes quality, regulatory alignment, and clear feedback to shape next-generation AI writing tools in clinical domains.

Qualifications

• Minimum 5 years of regulatory medical writing experience.
• Experience authoring full Clinical Study Reports.
• Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, E2C).
• Ability to read and interpret protocol documents and TFLs.
• Experience with eCTD placement.

Responsibilities

• Author and review clinical documents for AI tool development.
• Assess AI-generated content for regulatory compliance and accuracy.
• Provide structured, written rationales for assessments.
• Collaborate to refine evaluation frameworks and best practices.
• Trace narrative claims to source data and figures for verification.

Skills

Regulatory writing

Clinical Study Reports

ICH E3

eCTD knowledge

TFLs (tables, figures, listings)

Source data verification

Protocol interpretation

Feedback provision

AI-assisted documentation

Oncology and haematology

Education

Advanced degree in life sciences

Job description

Medical Writer / Clinical Document Author$50 - $80/hourpay

Required Skills regulatory medical writingclinical study report authoringich e3 guidelinesscientific accuracy assessmentsource data verificationclinical protocol interpretationtfl (tables, figures, listings) analysiswritten communicationstructured feedback provisioncollaborative problem-solvingai-assisted documentation evaluationperiodic safety documentation (ich e2f, ich e2c)ectd (electronic common technical document) knowledgeoncology and haematology domain expertise

About micro1

micro1 is the leading AI data lab for training frontier models and evaluating AI agents. Experts contribute their diverse subject matter knowledge across domains such as finance, healthcare, STEM engineering, and more. micro1 transforms that real-world expertise into high-quality training data, evaluations, and feedback loops that improve how AI systems learn, reason, and perform.

Our platform identifies and vets top talent through an AI recruiter, enabling high-quality expert contributions at scale. We aim to enable 1 billion people to do meaningful work by applying their expertise to AI. As our global expert network grows, micro1 is building the human intelligence layer for frontier AI.

Role Title: Medical Writer / Clinical Document Author

Role Type: Contractor

Location: Remote

micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customers 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 recordstables, figures, listings, and protocolsto 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.