Regulatory Medical Writer – FDA Submissions
$30 - $100/hourpay
Required Skills
FDA Regulatory submission writing
Clinical and regulatory documentation development
Regulatory guidelines and compliance expertise
Scientific and medical writing precision
About micro1
micro1 is a data engine that helps AI labs train foundational models and enterprises build AI agents. We provide frontier evaluations and reinforcement learning environments used to improve LLM capabilities, as well as contextual evaluations used to monitor and improve AI agents in enterprise settings. Our data engine includes an AI recruiter agent that sources and vets domain experts, a data platform that enables rapid production of high-quality training data, and a pipeline performance system that ensures both quality and velocity.
Our goal is to have 1 billion people doing meaningful work by contributing their expertise to the development of frontier AI models. We’ve raised $40M+ in funding, and our AI recruiter has powered more than 1 million AI-led interviews as our global network of experts expands to form the human intelligence layer for AGI.
Job Description
Job Title: Regulatory Medical Writer – FDA Submissions
Job Type: Contract (Full-time or Part-time)
Location: Remote
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.