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Medical Writer Regulatory Clinical (S200002 || BD MW 01)

Company: Pharmaceutical Biotechnology Company
Location: New Jersey
Category: Biotechnology

Job Description:
Job Description We are seeking a Medical Writer Regulatiory Clinical to join our team! The right candidate will have the following: At least 5 years medical writing experience Experience preparing clinical summary documents including Integrated Summaries of Safety and Efficacy for NDAs MAAs and or NDA Supplements in eCTD format Experience coordinating preparing Meeting Content Packages and responses to regulatory authorities as well as management preparation of clinical documents including clinical study reports and investigator brochures Resolve conflicting reviewer … (See More)
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