Regulatory Medical Writer for AI-Driven Clinical Docs (Remote)

SaidGig; New York (NY); Remote; USD 69,000 - 110,000; Full time

Job summary

SaidGig is seeking a regulatory medical writer to develop AI-assisted clinical documentation tools. You will create and assess realistic evaluation tasks and use expert judgment to improve how AI drafts, reviews, and validates regulatory content.

Prior AI experience is not required. You will author and review tasks based on CSRs, DSURs, and related documents, ensuring adherence to ICH E3 structures and eCTD placement.

Qualifications

• 5+ years of regulatory medical writing experience with a sponsor, CRO, or as an independent consultant.
• Experience 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 narrative content divergence from source data.
• Exceptional written and verbal communication skills, with the ability to provide structured, actionable clinical-content feedback.

Responsibilities

• Author and review evaluation tasks based on CSRs, DSURs, PSURs/PBRERs, and related documents.
• Assess whether AI-generated content meets clinical template and structural requirements (ICH E3, sequencing, references, appendices).
• Evaluate the scientific accuracy of efficacy, safety, discussion, and conclusions.
• Verify narrative claims against source records (tables, figures, listings, protocols).
• Provide clear, structured rationales to support diagnosis and AI-model improvement.
• Collaborate to refine evaluation frameworks and document best practices for AI-supported writing.

Skills

Regulatory medical writing

CSR authoring

ICH E3/E2F/E2C

eCTD knowledge

Clinical protocol interpretation

Structured scientific feedback

Cross-therapy experience

Education

Advanced degree in life sciences/pharmacy/medicine

Job description

SaidGig is seeking a regulatory medical writer to develop AI-assisted clinical documentation tools. You will create and assess realistic evaluation tasks and use expert judgment to improve how AI drafts, reviews, and validates regulatory content.

Prior AI experience is not required. You will author and review tasks based on CSRs, DSURs, and related documents, ensuring adherence to ICH E3 structures and eCTD placement.