Senior Medical Writer

Job Summary

A company is looking for a Senior Medical Writer in Regulatory Affairs.

Key Responsibilities:

• Lead the preparation of clinical study synopses, minutes for advisory boards, and clinical sections of regulatory documents
• Manage multiple medical writing projects and ensure compliance with regulatory guidelines and company standards
• Mentor and train junior medical writers and oversee the work of contract medical writers

Required Qualifications:

• Master's degree in a scientific or related field; PhD preferred
• 8+ years of experience in regulatory writing, particularly in Clinical Development
• Strong understanding of drug development, clinical study design, and relevant regulations
• Experience writing clinical study synopses and regulatory documents
• Proficiency in project management and document control processes