Scientific Writer – FDA Submissions | Remote
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.
Application Process (Takes 20 Min)
- Upload resume
- Interview (15 min)
- Submit form