Principal Med Writer

Overview

Lead medical and scientific writer providing high-quality documents from planning through final drafts for internal and external clients, with responsibility for reviewing and mentoring the team.

What you'll do

• Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
• Review documents for the team and provide training and guidance to junior team members.
• Advise on document development strategy, regulations and industry best practices.
• Demonstrate subject matter and therapeutic area expertise.
• Act as backup program manager.
• Collaborate with internal and external clients to support effective and efficient communication that results in operational excellence.
• Research, write, and edit clinical study reports and study protocols, and summarize data from clinical studies.
• Serve as primary author writing and providing input on complex clinical, scientific and program level documents, including IBs, INDs, and MAAs.
• Provide senior level review of routine and complex documents.
• Provide training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
• Ensure compliance with quality processes and requirements for assigned documents.
• As the subject matter expert, develop and review best practices, methods and techniques for achieving optimal results, including client-specific processes, and lead process improvement initiatives.
• Develop, review and manage performance metrics for assigned projects.
• Identify and resolve out-of-scope activities.
• Develop timelines, budgets, forecasts and contract modifications, and assist business development with client presentations, proposal text review and bid defense meetings and capabilities presentations.
• Represent the department at project launch meetings, review meetings, and project team meetings.

Details

• Work schedule: standard, Monday to Friday.
• Environmental conditions: office.