Medical Writer II

Job Summary

A company is looking for a Medical Writer II.

Key Responsibilities

• Conducts quality control reviews of clinical regulatory documents to ensure accuracy
• Maintains and uploads quality control documentation to the master file
• Prepares technical documents for regulatory submissions, incorporating various data formats

Required Qualifications

• Bachelor's degree required, preferably in Science, English, or Communication
• 2-3 years of relevant industry experience in quality control or related fields
• Strong knowledge of clinical regulatory documents and eCTD structure
• Experience with Common Technical Document (CTD) content templates
• Ability to work with limited oversight and in collaborative cross-functional teams