Job Details

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 documentsManage multiple medical writing projects and ensure compliance with regulatory guidelines and company standardsMentor and train junior medical writers and oversee the work of contract medical writersRequired Qualifications:Master's degree in a scientific or related field; PhD preferred8+ years of experience in regulatory writing, particularly in Clinical DevelopmentStrong understanding of drug development, clinical study design, and relevant regulationsExperience writing clinical study synopses and regulatory documentsProficiency in project management and document control processes