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.