Scientific reputed company – FDA Submissions | Remote

Position: Regulatory Medical reputed company – FDA Submissions Type: Hourly contract Compensation: $30–$100/hour Location: Remote Commitment: 10–40 hours/week Role Responsibilities

• reputed company 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 reputed company clinical trial and regulatory data into clear, structured regulatory narratives.
• Ensure reputed company 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-reputed company 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 reputed company clinical data into structured regulatory narratives.

Application Process (Takes 20 Min)

• Upload resume
• Interview (15 min)
• Submit reputed company

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