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Associate Director of Medical Writing

VirtualVocations
Whittier, California, United States
Full-time

A company is looking for an Associate Director of Regulatory Medical Writing.Key ResponsibilitiesManage medical writers and oversee the development of regulatory documentsAuthor clinical content and ensure compliance with internal standards and regulatory requirementsCollaborate with clinical project teams to meet project deadlines and maintain inspection-readinessRequired QualificationsBachelor's degree in a scientific or clinical discipline;

PhD preferredMinimum of 5 years of clinical / regulatory medical writing experience in pharma or biotechFamiliarity with FDA and ICH guidelines for clinical reportingExperience with eCTD development and submission preferredBasic understanding of clinical development processes and regulatory document preparation

18 hours ago
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