Principal Medical Writer

Job Summary

A company is looking for a Principal Medical Writer - GenAI and Regulatory Writing Innovation.

Key Responsibilities

• Provide medical writing leadership and author high-quality regulatory and clinical documents
• Lead innovation projects applying GenAI to optimize regulatory writing processes
• Mentor junior writers and contribute to departmental initiatives for continuous improvement

Required Qualifications

• Bachelor's degree in Life Sciences or a health-related discipline; advanced degree preferred
• At least 7 years of experience in the biopharmaceutical industry
• Minimum 5 years of hands-on medical writing experience for clinical regulatory submissions
• Demonstrated expertise in therapeutic area document requirements and global regulatory standards
• Familiarity with large language models and GenAI applications for writing and summarization