Associate Director Medical Writer

Job Summary

A company is looking for an Associate Director Medical Writer.

Key Responsibilities

• Lead medical writing projects and prepare scientific and regulatory documents for clinical development
• Document preparation includes CSRs, clinical investigator brochures, protocols, and sections of INDs and NDAs/BLAs
• Interpret and summarize biostatistical data into narrative text and liaise with internal groups

Required Qualifications

• PhD in life science/Pharm D preferred, or MS degree with 5+ years of experience
• Broad experience in pharmaceutical medical writing and clinical development, with knowledge of regulatory guidelines
• 3+ years of experience in medical writing focused on regulatory document preparation
• American Medical Writing Association (AMWA) certification is desirable
• Knowledge of US, ICH, and international regulations related to scientific and clinical document preparation