Associate Director of Medical Writing

Job Summary

A company is looking for an Associate Director, Medical Writing.

Key Responsibilities

• Lead the development of clinical/regulatory documents and manage assigned tasks within timelines
• Ensure high document quality and adherence to regulatory and internal guidelines
• Review and edit documents prepared by other writers or functional area representatives

Required Qualifications, Training, and Education

• Bachelor's degree in a life sciences discipline; an advanced degree is preferred
• Minimum of 5 years as a medical writer in the pharmaceutical industry, including 2 years of management experience
• Knowledge of IND/NDA/BLA/MAA submission requirements and familiarity with eCTD structure
• Excellent understanding of clinical development and industry regulatory requirements (ICH/FDA, GCP)
• Strong technological abilities, including proficiency in Microsoft Office and related software