Responsible for providing expertise to support the development of high-quality, fit-for-purpose clinical and regulatory documents.
Document Writing: Manages the assigned writing tasks and ensures that the documents adhere to relevant regulatory guidelines.
Project/Program Management: Navigates through uncertainties to develop and manage timeline of individual documents and multiple documents.
Process/Tool Establishment and Optimization: Identifies needs for process/tool optimization and establishment.
Training and Mentoring: Leads the development of new training programs and provides instructions to other MWs.

A n advanced degree (MS/PhD/PharmD/MD) in life science , pharmacy , medical , or health-related science is preferred.
BS with a minimum of 7 years of regulatory document writing (or equivalent) experience, master's with 5+ or PhD/PharmD/MD with a minimum of 3+ years of regulatory document writing (or equivalent) experience.
Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems.
Proficiency in Microsoft Outlook, Excel , and Power Point , etc.

Senior Principal Medical Writer

Key skills