Senior Staff Medical Writer

Job Summary

Leading the development of clinical evidence strategies, the full-time Senior Staff Medical Writer will work remotely to create scientific documentation that supports regulatory submissions and market access initiatives within the Neurovascular Division.

Key responsibilities

• Manage clinical evaluation projects, ensuring alignment between clinical evidence and regulatory strategy
• Author and maintain clinical evaluations, regulatory submissions, and other clinical documentation
• Design and execute systematic literature reviews, synthesizing clinical and technical data into evidence-based conclusions

Required qualifications

• Master of Science degree in a health, clinical, biological science, biomedical, engineering, or related field
• Minimum 6 years of experience in clinical affairs, regulatory affairs, or medical writing
• At least 2 years of experience authoring clinical evaluations for medical devices
• Experience conducting literature reviews and scientific analysis using clinical data
• Experience supporting regulatory submissions within a regulated healthcare industry