Senior Medical Writer

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