Job Title
Medical Writer / Clinical Document Author -AI Trainer
Job Type
Contractor
Compensation Structure
Compensation is output-based. Experts are paid per task that meets the project specifications. The time required to complete work may vary depending on experience and workflow. Minimum submission requirements apply.
Location
Remote
Job Summary
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 expertise in regulatory medical writing and clinical documentation is what matters most.
You'll contribute to the development of AI-assisted writing tools by evaluating, reviewing, and improving clinical regulatory documents while ensuring compliance with industry standards and scientific accuracy.
Key Responsibilities
- Author and review evaluation tasks based on Clinical Study Reports (CSRs), DSURs, PSURs/PBRERs, and related clinical documents.
- Evaluate AI-generated content for compliance with clinical document structures, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
- Assess scientific accuracy in efficacy, safety, discussion, and conclusion sections, distinguishing factual issues from stylistic differences.
- Verify narrative claims by tracing them back to source documents, including tables, figures, listings, and study protocols.
- Provide detailed written feedback and structured rationales to support AI model improvement.
- Collaborate with project leads to refine evaluation frameworks and establish best practices for AI-assisted clinical regulatory writing.
Required Skills and Qualifications
- Minimum of 5 years of regulatory medical writing experience at a pharmaceutical sponsor, CRO, or as an independent consultant.
- Demonstrated experience independently authoring or leading the development of complete Clinical Study Reports (CSRs).
- Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD submission standards.
- Ability to interpret TFLs (Tables, Figures, and Listings) and clinical protocols while validating narrative accuracy.
- Excellent written and verbal communication skills with exceptional attention to detail.
- Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field (PhD, PharmD, MD, MSc), or equivalent professional experience.
Preferred Qualifications
- Experience across multiple therapeutic areas and clinical development phases.
- Oncology or hematology regulatory writing experience.
- Previous experience reviewing or evaluating AI-generated clinical content.
- Strong background in regulatory document quality assurance and clinical documentation best practices.
Start Timeline & Availability
We typically fill roles within 48 hours and are looking for professionals ready to begin quickly. If selected, you'll be expected to start your first tasks within 24–48 hours after completing onboarding.
Job Type: Contract
Pay: $50.00 - $80.00 per hour
Benefits:
Work Location: Remote
