Regulatory Medical Writer – FDA Submissions

micro1 connects top-tier talent with frontier AI labs and Fortune 10 companies — and right now they need a Regulatory Medical Writer who knows FDA submissions inside out. This isn’t generic content work. You’ll be shaping how AI models understand biomedical regulatory language, which means your CSR, IB, and CTD expertise has direct impact on the next generation of AI tools. Pay ranges from $30 to $100/hr depending on experience, fully remote, contract basis.

What you’ll do

• Develop specialized prompts and evaluate AI-generated regulatory content for FDA compliance accuracy
• Review and annotate Clinical Study Reports (CSR), Investigator’s Brochures (IB), and CTD/Module 2 summaries
• Apply ICH guidelines to assess AI outputs on NDAs, INDs, and related submission documents
• Provide structured written feedback to improve AI model performance in biomedical regulatory contexts

What they’re looking for

• Direct experience writing or reviewing FDA regulatory submissions (CSR, IB, NDA, IND, CTD/Module 2)
• Strong working knowledge of ICH guidelines and FDA compliance requirements
• Background in life sciences, pharmacology, or a related biomedical field
• Nice to have: experience with AI/ML tools or prior work in AI training and evaluation

Compensation

• Pay: $30–$100/hr (based on expertise level)
• Type: Contract, hourly
• Benefits: Fully remote, flexible schedule

How to apply

1. Click the apply link below to visit the micro1 job page
2. Complete your profile and any required assessments
3. Submit your application for this role

Apply Now →