Medical Writer

Role Summary

Reporting directly to the Vice President of Clinical Development, the Medical Writer will be responsible for leading and executing all medical writing activities supporting Xeris’s 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.

Responsibilities

• Develop and author a broad range of clinical and regulatory documents, including but not limited to: clinical study protocols, investigator brochures (IBs), clinical study reports (CSRs), and sections of regulatory submissions (e.g., IND, NDA, etc.).
• Ensure accuracy, clarity, consistency, and compliance with internal standards, applicable regulatory guidelines (e.g., ICH, FDA, EMA), and company SOPs.
• Collaborate cross-functionally with colleagues in Clinical, Regulatory Affairs, Medical Affairs, and other internal stakeholders to gather relevant data and ensure consistency of messaging across documents.
• Translate highly technical and statistical information into clear, concise content suitable for a wide variety of audiences including regulators, healthcare professionals, and non-scientific business leaders, as required.
• Contribute to the development of communication materials, including slide decks, manuscripts, abstracts, and presentations, to support internal and external scientific communications.
• Maintain document quality control through proofreading, editing, and adherence to templates, style guides, and version control procedures.
• Manage timelines and priorities for multiple projects simultaneously, ensuring timely and accurate delivery of high-quality documents.
• Provide detailed medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
• Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines and complies with departmental SOPs and style guidelines.
• Perform literature searches and reviews as necessary to obtain background information and provide literature references.
• 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, and lead discussion on document revision and finalization for both internally written and outsourced documents.
• Serve as a point person for medical writing guidance and document-related problem resolution.

Qualifications

• Bachelor’s degree in Life Sciences or a related field is required; advanced degree (PhD, PharmD, or MS) strongly preferred.
• Minimum of 5 years of medical writing experience in the pharmaceutical, biotechnology, or clinical research industry, with a focus on late-stage clinical development (Phase 3).
• Demonstrated experience in writing regulatory submission documents in compliance with regulatory agency guidelines.
• Proficiency in Microsoft Office Suite and familiarity with document management systems and version control tools.
• Competencies: Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Independent Judgement, Cross-Team Collaboration, Critical Thinking, Problem Solving.
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid position located in Xeris’s Chicago office and requires three days per week on-site. On-site requirement may change at management’s discretion.