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Associate Director of Medical Writing

Company: VirtualVocations
Location: Vista
Posted on: May 24, 2025

Job Description:

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

Keywords: VirtualVocations, Mission Viejo , Associate Director of Medical Writing, Executive , Vista, California

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