Contract Medical Writer

Job Summary

Working remotely on a contract basis, the Contract Medical Writer will manage various medical writing activities, including the creation and editing of clinical trial documents, while ensuring compliance with regulatory standards.

Key responsibilities

• Collaborate with internal and external teams to develop and maintain clinical trial documents and templates
• Lead the development and implementation of study protocols, amendments, and regulatory submissions
• Ensure compliance with regulatory requirements and manage project timelines and quality control

Required qualifications

• BS/BA in a health-related or life science-related field; Master's degree preferred
• Minimum of 5 years of relevant experience in medical writing
• Extensive experience in the design, execution, and analysis of clinical studies
• Experience in the Contract Research Organization (CRO) industry is preferred
• Familiarity with regulatory guidelines, drug development, and clinical trial methodology