Principal Medical Writer

• Provide high-quality medical and scientific writing from planning and coordination through final drafts for internal and external clients
• Lead writing activities and review team documents
• Provide training, mentorship, and guidance to junior writers and program managers
• Advise on document development strategy, regulations, and industry best practices
• Research, write, and edit clinical study reports and study protocols
• Summarize data from clinical studies
• Serve as primary author for complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs
• Ensure compliance with quality processes and requirements for assigned documents
• Develop and review best practices, methods, and techniques, including client-specific processes
• Lead process improvement initiatives
• Develop, review, and manage performance metrics for assigned projects
• Serve as backup program manager and identify and resolve out-of-scope activities
• Develop timelines, budgets, forecasts, and contract modifications as needed
• Assist business development with client presentations and proposal text review
• Attend bid defense meetings and capabilities presentations
• Represent the department at project launch, review, and project team meetings
• Collaborate with internal and external clients to support effective communication and operational excellence

• Demonstrated subject matter and therapeutic area expertise
• Experience researching, writing, and editing clinical study reports and study protocols
• Ability to summarize data from clinical studies
• Ability to author complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs
• Ability to provide senior-level review of routine and complex documents
• Knowledge of document preparation software and document types
• Knowledge of regulatory requirements and therapeutic areas
• Ability to ensure compliance with quality processes and requirements
• Ability to develop and review best practices, methods, and techniques
• Ability to lead process improvement initiatives
• Ability to develop, review, and manage performance metrics
• Ability to serve as backup program manager
• Ability to develop timelines, budgets, forecasts, and contract modifications
• Ability to assist with client presentations, proposal text review, bid defense meetings, and capabilities presentations

• Fully remote work arrangement
• Standard Monday–Friday work schedule