Senior Medical Writer

Responsibilities

• Lead the planning, writing, editing, and QC review of clinical study documents
• Manage document flow effectively from template to final approval
• Independently formulate key messages from clinical data
• Author complex documents using regulatory knowledge
• Communicate clearly with internal and external teams both verbally and in writing
• Contribute to the development of medical writing processes and SOPs
• Conduct literature-based research to enhance written content

Qualifications

• 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 in Microsoft Teams, Word, Excel, Adobe Acrobat, and PowerPoint
• In-depth knowledge of ICH, FDA, GCP regulations, and eCTD requirements
• Exceptional attention to detail with timely document completion
• Advanced degree (MS/PhD) preferred, with oncology or rare disease experience

Benefits

• Health insurance coverage
• Retirement savings plans
• Disability and life insurance
• Parental leave policy
• Paid time off for sick leave and vacation
• Eligibility for a discretionary annual bonus