Principal Clinical Medical Writer

Job Summary

Focusing on the development of the medical writing function, the full-time Principal Clinical Medical Writer will oversee medical writing staff, manage timelines for clinical documentation, and author/edit essential documents for clinical studies in a remote setting.

Key responsibilities:

• Oversee Medical Writing staff and manage timelines for program planning
• Draft and edit clinical study documents, including protocols and clinical study reports
• Represent the Clinical Medical Writing team at cross-functional meetings and ensure adherence to departmental standards

Required qualifications:

• Advanced understanding of the drug development process and clinical research concepts
• Experience writing and editing regulatory documents such as INDs and clinical study reports
• Prior management experience in a medical writing team preferred
• Master's degree or higher in a scientific field preferred
• Evidence of medical writing career development, such as relevant certifications