Principal Med Writer

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description

Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. As the lead writer, reviews documents for the team and provides training and guidance to junior team members. Provides advice on document development strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Acts as backup program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies. Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.

• Serves as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
• Provides senior level review of routine and complex documents. Provides 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.