Regulatory Medical Writer – FDA Submissions

Job Summary

Join our customer’s team as a Regulatory Medical Writer specializing in FDA submissions. This unique opportunity allows you to leverage your regulatory expertise to support the training and evaluation of advanced AI models in partnership with a leading AI lab. Your contributions will directly influence the accuracy and quality of AI systems used in the biomedical and regulatory sector.

Key Responsibilities

Develop structured prompts and comprehensive evaluation rubrics modeled on FDA regulatory submission workflows. Author and review exemplary regulatory documentation, including clinical narratives and regulatory dossiers. Assess AI-generated content for accuracy, regulatory compliance, and scientific rigor. Translate complex clinical and regulatory data into clear, structured, and compliant regulatory narratives. Ensure all written materials align with FDA guidance, industry standards, and evolving regulatory requirements. Identify and document errors, inconsistencies, or hallucinations in AI-generated regulatory texts. Collaborate with cross-functional teams to enhance the quality and consistency of submission-ready content.

Required Skills and Qualifications

Proven experience preparing FDA regulatory submissions for pharmaceutical or biotech products. Mastery of key regulatory documents, including Clinical Study Reports (CSR), Investigator’s Brochure (IB), NDAs, INDs, and CTD/Module 2 summaries. In-depth knowledge of ICH guidelines, FDA regulatory frameworks, and submission standards. Demonstrated ability to develop and revise regulatory documentation with scientific precision and compliance. Expert written and verbal communication skills, with meticulous attention to detail and structure. Experience collaborating effectively with cross-functional clinical development teams. Track record of translating clinical trial data into structured, regulatory narratives.

Preferred Qualifications

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