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Regulatory Medical Writer – AI FDA Submissions Project
USA Contract
About the Role
We are inviting experienced Regulatory Medical Writers to contribute their expertise to projects at the intersection of clinical documentation, FDA compliance, and advanced AI systems. In this role, you will leverage your regulatory expertise to support the training and evaluation of advanced AI models in partnership with a leading AI lab. This remote opportunity is ideal for specialists in FDA submissions who are interested in applying their mastery of clinical narratives and dossiers to ensure the accuracy and quality of emerging AI technologies in the biomedical sector.
What You'll Do
- Develop structured prompts and comprehensive evaluation rubrics modeled on FDA regulatory submission workflows
- Author and review exemplary regulatory documentation, including clinical narratives and dossiers
- Assess AI-generated content for accuracy, regulatory compliance, and scientific rigor
- Identify and document errors, inconsistencies, or hallucinations in AI-generated regulatory texts
- Evaluate model reasoning related to Clinical Study Reports (CSR), Investigator’s Brochures (IB), and NDAs
- Collaborate with AI researchers and technical teams to improve the quality of submission-ready datasets
- Ensure AI outputs align with FDA guidance, ICH guidelines, and evolving industry standards
Requirements
- Proven experience preparing FDA regulatory submissions for pharmaceutical or biotech products
- Mastery of key regulatory documents, including NDAs, INDs, and CTD/Module 2 summaries
- In-depth knowledge of ICH guidelines, FDA regulatory frameworks, and submission standards
- Track record of translating complex clinical trial data into structured, compliant regulatory narratives
- Advanced skills in scientific and medical writing with meticulous attention to detail
- Strong analytical thinking and the ability to communicate complex regulatory concepts clearly
- Ability to work independently in a remote consulting environment
Application Note: By submitting your profile for this partnered position, our team can quickly review your background and reach out to present you with this specific opportunity or match you with similar AI Training projects.