Principal Medical Writer

Job Summary

Working remotely, the full-time salaried Principal Medical Writer will develop and manage high-quality regulatory documents, ensuring compliance and scientific accuracy throughout the writing process.

Key responsibilities

• Develop and write regulatory submissions, including clinical study protocols and clinical study reports
• Collaborate with cross-functional teams to ensure alignment on project objectives and timelines
• Review and edit documents for clarity, consistency, and adherence to regulatory guidelines

Required qualifications

• Advanced degree in a relevant scientific discipline (PhD, MD, or equivalent)
• Minimum of 5 years of experience in medical writing, particularly in regulatory submissions
• Strong understanding of regulatory requirements and guidelines
• Experience working in a pharmaceutical or biotechnology environment
• Proficiency in using document management systems and writing tools