We are seeking a Regulatory Medical Writer to support FDA submissions on an hourly contract basis. This remote position requires a commitment of 10–40 hours per week, with compensation ranging from $30 to $100 per hour.

The Role

In this role, you will develop structured prompts and evaluation rubrics based on FDA regulatory submission workflows, author and review regulatory documentation, and evaluate AI-generated content for accuracy and compliance. You will translate complex clinical trial data into clear narratives and ensure all documentation adheres to FDA guidance and ICH standards.

Responsibilities

• Develop structured prompts and evaluation rubrics for FDA submission workflows.
• Author and review regulatory documents such as clinical narratives and submission summaries.
• Evaluate AI-generated regulatory content for scientific accuracy and compliance.
• Translate complex clinical trial and regulatory data into clear narratives.
• Ensure documentation aligns with FDA guidance and ICH standards.
• Identify inconsistencies and errors in AI-generated documents.
• Collaborate with cross-functional teams to enhance submission-ready materials.

Requirements

• Proven experience in preparing FDA regulatory submissions for pharmaceutical or biotechnology products.
• Strong expertise in regulatory documents including Clinical Study Reports (CSR), Investigator’s Brochure (IB), NDAs, INDs, and CTD Module 2 summaries.
• In-depth knowledge of ICH guidelines and FDA regulatory frameworks.
• Ability to produce precise and compliant regulatory documentation.
• Excellent written and verbal communication skills with a keen attention to detail.
• Experience collaborating with clinical development and regulatory teams.
• Ability to translate complex clinical data into structured narratives.

Application Process

To apply, please upload your resume and complete a brief form. The interview process will take approximately 15 minutes. We look forward to your application!