Medical Writer / Clinical Document Author

Role Overview

Apply your regulatory medical writing expertise to help develop AI-assisted clinical documentation tools. You will create and assess realistic clinical-documentation evaluation tasks, using expert judgment to improve how AI systems draft, review, reason about, and validate regulatory content. Prior AI experience is not required.

Key Responsibilities

• Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents.
• Assess whether AI-generated content meets clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-references, and appendix management.
• Evaluate the scientific accuracy of efficacy, safety, discussion, conclusion, and other narrative sections, separating scientific or interpretive errors from stylistic differences.
• Verify narrative claims against source records, including tables, figures, listings, and protocols.
• Provide clear, structured written rationales that support diagnosis and improvement of AI model behavior.
• Collaborate with project leads to refine evaluation frameworks and document best practices for AI-supported clinical regulatory writing.

Qualifications

• At least 5 years of regulatory medical writing experience with a sponsor, CRO, or as an independent consultant.
• Experience independently authoring or leading the authoring of complete Clinical Study Reports, beyond summaries or partial contributions.
• Fluency with ICH E3, periodic safety-documentation conventions including ICH E2F and ICH E2C, and eCTD placement.
• Ability to interpret TFLs and clinical protocols and identify when narrative content diverges from source data.
• Exceptional written and verbal communication skills, including the ability to provide structured, actionable clinical-content feedback.
• An advanced degree in life sciences, pharmacy, or medicine, such as PhD, PharmD, MD, or MSc, or equivalent depth of authoring experience.
• Experience across multiple clinical phases and therapeutic areas. Oncology and haematology expertise is particularly valued.

Work Terms

• Remote contract engagement.
• Independent contractor role.

Compensation

$50 to $80 per hour.

Eligibility

This role requires the stated regulatory medical writing experience and demonstrated clinical-document authoring expertise.