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 Responsibilities
* Working 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 & Experience
* Bachelor's degree (physical or biological sciences) with 5 years of relevant experience
* MS with 4years of experience
* Doctoral-level degree (eg, PhD, MD, DVM, DO, PharmD) with 3years of relevant career experience.
Skills
* English fluency required, level C2 or native speaker preferred
* Demonstrated ability to understand and apply scientific concepts
* Good understanding of statistical principles
Values
* Care
* Courage
Senior Medical Writer
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