Medical Writer / Clinical Document Author
$50 - $80 per hourSaidGig
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.
Vacancy posted a month ago
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