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)

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