Medical Writer

Job Summary

A company is looking for a Medical Writer.

Key Responsibilities

• Provide medical writing services and consultation, including writing and editing scientific documents
• Lead the content planning and production of regulatory documents, ensuring compliance with established standards
• Act as the primary contact for external publication specialists and manage writing deliverables and timelines

Required Qualifications

• Minimum of an undergraduate degree (advanced degrees preferred) and 3-5 years of relevant experience in medical writing
• Previous experience leading the development of protocols, informed consent forms, and clinical study reports
• Trained in Good Clinical Practice (GCP), General Data Protection Regulation (GDPR), and Health Insurance Portability and Accountability Act (HIPAA)
• Advanced knowledge of EndNote/reference software
• Familiarity with ICH M11 and the AMA Style Guide is an asset