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Regulatory Medical Writer – FDA Submissions
Micro1 • Remote
Education
Any
Type
Pay Rate (by country)
$30–$100/task
Listed
144d ago
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About this Role
From the Micro1 listing
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.
Requirements
- Must be eligible to work in Remote
- Fluent proficiency in English (Written & Verbal)
- Reliable high-speed internet connection
- Bachelor's degree or equivalent professional experience
- Demonstrated expertise in Writing
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.
Why This Role
No office, no fixed hours, no relocation. This Regulatory Medical Writer – FDA Submissions role pays $65/hr fully remote, giving you access to Writing work that would otherwise be limited to a handful of major cities.
Skills & Categories
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Frequently Asked Questions
Can I apply to Micro1 from outside the US or UK?
Yes. Micro1 accepts applicants from most countries worldwide, unlike DataAnnotation or Outlier, both of which cap access to a handful of English-speaking countries. Most roles still require strong written and spoken English.
Does Micro1 monitor your computer while you work?
On many projects, yes, through time-tracking tools that take periodic screenshots to verify active hours. Check the specific project's requirements before accepting if desktop monitoring is a dealbreaker.
What does the Micro1 application process look like?
Expect a screening interview with Zara, Micro1's AI recruiter. Prepare for it like a real video call: good lighting, clear audio, verbal answers to technical questions. A human manager reviews the recording afterward, and some roles add a short skills assessment on top.
What equipment do I need for creative AI training roles?
For voice or audio roles at this pay level, a professional home studio setup (XLR microphone, acoustically treated room) is typically required. Phone recordings and laptop mics usually get rejected by quality control.
How is my creative work actually used in AI training?
As ground-truth data: for writers, that means creative generation samples; for voice actors, it often means training text-to-speech models. Check the specific contract details on rights usage for your voice or likeness before signing.
Do creative AI training roles allow creative freedom?
Some, within limits. You're hired for your talent, but most projects still require following strict style guides, like keeping a neutral tone or matching a technical-manual style. Consistency across the dataset matters more than personal expression here.
What does Writing work look like for a Regulatory Medical Writer – FDA Submissions?
Tasks here are scoped to Writing, not generic labeling. As a Regulatory Medical Writer – FDA Submissions, expect to draw on real domain judgment (evaluating outputs, correcting errors, or providing expert reasoning specific to Writing) rather than following a one-size-fits-all rubric. If you don't have hands-on Writing background, this is likely not the right listing to start with.
What happens when I click Apply on this listing?
You'll be taken to Micro1's external site to complete your application there. This listing links through a referral, but the process is identical to applying directly; the link just routes you correctly. Create an account on their site and follow their onboarding steps.