Medical Writer

Medical Writer responsible for leading and executing all medical writing activities supporting Xeris' clinical programs. The individual will have a strong scientific background, exceptional writing skills, and a proven ability to translate complex clinical and scientific data into clear, accurate, and regulatory-compliant documents tailored to diverse audiences.

Requirements

• Develop and author clinical and regulatory documents
• Ensure accuracy, clarity, consistency, and compliance with regulatory guidelines and company SOPs
• Collaborate with colleagues in Clinical, Regulatory Affairs, Medical Affairs, and other internal stakeholders
• Translate technical information into clear, concise content
• Maintain document quality control through proofreading, editing, and adherence to templates and style guides
• Manage timelines and priorities for multiple projects simultaneously
• Provide detailed medical editing review of draft and final documents
• Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines
• Perform literature searches and reviews as necessary
• Provide input on processes, templates, and other business needs within the medical writing function
• Coordinate and/or manage review cycles to triage, incorporate, and resolve team comments

Benefits

• Multiple paid time off benefits
• Various health insurance options
• Retirement benefits