Senior Medical Writer

Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing. Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership. Other duties as assigned. **Necessary Skills and Abilities:**Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information.Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines.Advanced understanding of regulatory submission requirements and processes. Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures.Exceptional ...