Position Summary:
The Senior Medical Writer/Principal Medical Writer will be responsible for leading the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete MW activities with impeccable attention to detail.