Associate Director of Medical Writing
Company: VirtualVocations
Location: Bridgeport
Posted on: October 30, 2024
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Job Description:
A company is looking for an Associate Director of Regulatory
Medical Writing.
Key Responsibilities
Manage medical writers and oversee the development of regulatory
documents
Author clinical content and ensure compliance with internal
standards and regulatory requirements
Collaborate with clinical project teams to meet project deadlines
and maintain inspection-readiness
Required Qualifications
Bachelor's degree in a scientific or clinical discipline; PhD
preferred
Minimum of 5 years of clinical/regulatory medical writing
experience in pharma or biotech
Familiarity with FDA and ICH guidelines for clinical reporting
Experience with eCTD development and submission preferred
Basic understanding of clinical development processes and
regulatory document preparation
Keywords: VirtualVocations, Chicopee , Associate Director of Medical Writing, Executive , Bridgeport, Massachusetts
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