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Associate Director of Medical Writing

Company: VirtualVocations
Location: Bridgeport
Posted on: October 30, 2024

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, Bloomfield , Associate Director of Medical Writing, Executive , Bridgeport, New Jersey

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