Associate Director of Medical Writing

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

Apr 24, 2025 - 20:02

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