Medical Writer

• Title: Medical Writer (Remote)
• Engagement: Hourly contract (independent contractor)
• RATE: USD 30-100 /Hour

Job Summary

One of our clients is seeking a Regulatory Medical Writer with strong experience in FDA submissions to support an AI training and evaluation project. In this role, you will apply your regulatory and scientific writing expertise to help develop, review, and evaluate regulatory documentation used to train advanced AI models. Your work will contribute to improving the accuracy and reliability of AI systems used in biomedical research and regulatory environments.

Key Responsibilities

• Develop structured prompts and evaluation frameworks based on FDA regulatory submission workflows.
• Author and review high-quality regulatory documentation including clinical narratives and submission-related materials.
• Evaluate AI-generated regulatory content for accuracy, compliance, and scientific integrity.
• Translate complex clinical and regulatory information into clear, structured regulatory narratives.
• Ensure all documentation aligns with FDA guidance, regulatory standards, and industry best practices.
• Identify inconsistencies, errors, or unsupported claims in AI-generated regulatory texts and provide corrections.
• Collaborate with cross-functional teams to improve the quality and clarity of submission-ready documentation.

Required Skills and Qualifications

• Proven experience preparing FDA regulatory submissions within pharmaceutical or biotechnology environments.
• Strong expertise in regulatory documents such as Clinical Study Reports (CSR), Investigator’s Brochure (IB), NDAs, INDs, and CTD or Module 2 summaries.
• Deep understanding of ICH guidelines, FDA regulatory frameworks, and submission standards.
• Demonstrated ability to produce and revise regulatory documentation with scientific accuracy and compliance.
• Excellent written and verbal communication skills with strong attention to detail and structure.
• Experience collaborating with clinical development and regulatory teams.
• Ability to translate clinical trial data into structured regulatory narratives.

Preferred Qualifications

• Background working in CROs, pharmaceutical companies, or regulatory consulting environments.
• Familiarity with eCTD submissions and regulatory document lifecycle management.
• Experience using AI-assisted medical writing tools or regulatory automation workflows.