Position: Regulatory Medical Writer FDA Submissions

Type: Contract

Compensation: $30 - $100/hour

Location: Remote

Commitment: 10-40 hrs/week

Role 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.

Requirements

• Have proven experience preparing FDA regulatory submissions for pharmaceutical or biotech products.
• Demonstrate mastery of key regulatory documents, including Clinical Study Reports (CSR), Investigator s Brochure (IB), NDAs, INDs, and CTD/Module 2 summaries.
• Possess in-depth knowledge of ICH guidelines, FDA regulatory frameworks, and submission standards.
• Demonstrate the ability to develop and revise regulatory documentation with scientific precision and compliance.
• Have expert written and verbal communication skills, with meticulous attention to detail and structure.

Application Process

• Easy Apply on LinkedIn
• Check email for next steps
• Participate in resume evaluation & interview stage