Associate Medical Writer

Job Summary

A company is looking for an Associate Medical Writer to produce and review clinical documentation.

Key Responsibilities

• Write and review Essential Documents and clinical study report patient safety narratives
• Collect and track documents for CSR appendices and perform quality control reviews
• Collaborate with teams to develop patient safety narratives and assess clinical study data

Required Qualifications

• Bachelor's/Master's degree in biomedical or life sciences, or relevant experience
• Minimum 2 years of experience in clinical documentation and data
• Experience in pharmaceutical, biotechnology, or contract research organizations
• Basic knowledge of FDA, ICH regulations, and eCTD requirements