Medical Writer / Clinical Document Author

SaidGig; New York (NY); Remote; USD 69.000 - 110.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory medical writing

CSR authoring

ICH E3/E2F/E2C

eCTD knowledge

Clinical protocol interpretation

Structured scientific feedback

Cross-therapy experience

Ausbildung

Advanced degree in life sciences/pharmacy/medicine

Jobbeschreibung

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.