Scientific Writer – FDA Submissions

Position: Regulatory Medical Writer – FDA Submissions

Type: Hourly contract

Compensation: $30–$100/hour

Location: Remote

Commitment: 10–40 hours/week

Role Responsibilities
• Develop structured prompts and evaluation rubrics based on FDA regulatory submission workflows.
• Author and review regulatory documentation such as clinical narratives, regulatory dossiers, and submission summaries.
• Evaluate AI-generated regulatory content for scientific accuracy, regulatory compliance, and completeness.
• Translate complex clinical trial and regulatory data into clear, structured regulatory narratives.
• Ensure all documentation aligns with FDA guidance, ICH standards, and regulatory compliance requirements.
• Identify inconsistencies, errors, or hallucinations in AI-generated regulatory documents.
• Collaborate with cross-functional teams to improve the quality and consistency of submission‑ready materials.

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

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