Principal Medical Writer

Job Summary

A company is looking for a Principal Medical Writer to lead the development of regulatory and clinical documents.

Key Responsibilities

• Lead the preparation and review of clinical study reports, protocols, and other regulatory documents
• Collaborate with cross-functional teams to gather and synthesize information for document development
• Mentor and train junior medical writers while ensuring adherence to regulatory requirements and internal standards

Required Qualifications, Training, and Education

• Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred
• Significant experience in medical writing, particularly in regulatory submissions and clinical documentation
• Strong understanding of regulatory requirements and industry standards for clinical writing
• Exceptional writing and editing skills
• Commitment to maintaining high standards of quality and compliance in all medical writing activities