The Senior Medical Writer serves as a key contributor to regulatory and clinical projects, leveraging a scientific background and writing expertise to produce high quality strategic and operational documents.Tasks and ResponsibilitiesWorking with the project and trial teams, the Senior Medical Writer takes leadership responsibility for the timely authoring, review, finalization, and approval of regulated documents for development and marketed products. Documents may include but are not limited to electronic Common Technical Document (eCTD) modules, health authority briefing packages, and clinical trial operational documents (eg, protocols, lay summaries, Investigator Brochures).Contributes to the creation and implementation of robust systems for document development and management.Serves as the medical writing content expert to regulatory and clinical development teams, including trial and project teams.Education & ExperienceBachelor's degree (physical or biological sciences) with 5 years of relevant experienceMS with 4years of experienceDoctoral-level degree (eg, PhD, MD, DVM, DO, PharmD) with 3years of relevant career experience.SkillsEnglish fluency required, level C2 or native speaker preferredDemonstrated ability to understand and apply scientific conceptsGood understanding of statistical principlesValuesCareCourageSenior Medical WriterJ-18808-Ljbffr
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