Senior Medical Writer

Leading the development of high-quality clinical study documents, the remote Senior Medical Writer will manage clinical document planning, writing, editing, and QC review while ensuring compliance with regulatory guidelines. Key responsibilities: Plan, write, edit, format, and perform QC review of clinical documents, ensuring alignment with regulatory requirements Oversee document management processes from initial template to final approved version in collaboration with internal and external teams Independently formulate key messages from clinical study data and contribute to the development of medical writing processes and templates Required qualifications: BS degree or equivalent in a scientific or medical discipline with relevant writing expertise 5+ years of experience as a Senior Medical Writer in a sponsor and/or CRO setting or 7+ years as a Principal Medical Writer Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint Clear understanding of ICH, FDA, GCP regulations, and eCTD requirements Impeccable attention to detail and ability to manage multiple high-priority projects effectively