leading the development of high-quality and on-time clinical study documents
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
ensures smooth and effective document management from start to finish (ie, from template to final, approved version)
ability to independently formulate key messages from clinical study data
contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents
performing literature-based research to support writing activities

BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
5+ years of experience as a medical writer in the sponsor and/or CRO setting
Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint
Clear understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, EudraCT, CT.gov), and eCTD requirements for all phases of development
Impeccable attention to detail and ability to complete writing assignments in a timely manner
Ability to work effectively in a fast-paced environment with multiple high priority projects with no instruction on routine work and minimal instruction on new assignments

Senior Medical Writer

Key skills