Associate Medical Writer

Job Summary

A company is looking for an Associate Medical Writer.

Key Responsibilities

• Writes, edits, and reviews clinical documentation, including informed consent forms and patient information
• Finalizes and tracks clinical study report (CSR) patient safety narratives
• Performs quality control reviews of documents and collaborates with the narrative automation team

Required Qualifications

• College or university degree in biomedical or life sciences, or equivalent experience
• Minimum 2 years of industry experience in medical and/or regulatory writing
• Experience in pharmaceutical, biotechnology, or contract research organizations
• Basic knowledge of global regulations (FDA, ICH) related to drug development
• Familiarity with electronic Common Technical Document (eCTD) requirements