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Principal Medical Writer

VirtualVocations
Santa Clara, California, United States
Full-time

A company is looking for a Principal Medical Writer to lead the development of clinical and regulatory documents.Key ResponsibilitiesLead the development of clinical study protocols, amendments, investigator's brochures, and other supporting documentsCo-author clinical study reports (CSRs) and data summaries for regulatory submissionsCollaborate with cross-functional teams to ensure compliance with ethical and regulatory standardsRequired QualificationsBachelor's degree in a scientific discipline;

advanced degree (MS, PhD, MD, PharmD) is a plusA minimum of 6+ years of experience in pharmaceutical medical writing or related disciplinesProven track record of managing clinical study protocols and regulatory submission documentsStrong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirementsExperience with drug-drug and biologic-biologic combination products is a plus

4 days ago
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