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Associate Director Medical Writing

VirtualVocations
Fremont, California, United States
Full-time

A company is looking for an Associate Director, Medical Writing to oversee medical writing activities for clinical development programs.

Key Responsibilities : Lead writing strategy and ensure timely delivery of high-quality regulatory documentsManage deliverables and preparation of documents for submission to regulatory agenciesRepresent Medical Writing on cross-functional teams and serve as lead writer for key regulatory submissionsRequired Qualifications : Advanced degree in a relevant scientific / clinical / regulatory field preferred;

Bachelor's degree requiredAt least 10 years of experience writing clinical / regulatory documents in the pharmaceutical or biotechnology industryExperience as lead writer for major US and / or international regulatory submissionsDemonstrated ability to manage writing activities and resources across projectsWorking knowledge of current global regulatory requirements and guidelines applicable to clinical research

7 days ago
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