Associate Director, Medical Writing

Summary

Join Ultragenyx, a biopharmaceutical company focused on rare disease medicine, as an Associate Director, Medical Writing. You will be responsible for writing and coordinating clinical and regulatory documents, working closely with cross-functional teams. This remote position requires strong medical writing, editing, and clinical development experience, including experience with eCTD/NDA submissions. The ideal candidate will possess strong leadership and project management skills and be proficient in relevant software. Ultragenyx offers a competitive salary, annual bonus, equity incentives, and a comprehensive benefits package including generous vacation time, volunteer days, and professional development opportunities.

Requirements

• BS, MS, or doctorate in a scientific or medical field
• Six+ years in the biotechnology/pharmaceutical industry
• Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission a plus
• Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support
• Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects
• Proven ability to develop and implement medical writing processes and standards
• Exceptional oral and written communication skills
• Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design; Project and Visio a plus)

Responsibilities

• Development and implementation of cross-functional input for clinical and regulatory documents including the drafting, editing, reviewing, and ensuring quality of key messages, protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, response documents, and briefing books
• Ensures smooth, effective, and timely document management from start (template) to finish (approval), which may include: first-draft authoring, literature and reference retrieval, editing, efficient comment resolution, and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving) with high quality
• Actively supports cross-functional project teams as the Clinical Regulatory Writing representative, providing input to ensure timely and accurate deliverables and negotiating timelines as necessary
• Proactively implements clinical transparency and disclosure practices in document development (e.g. Policy 70, Clintrials.gov, etc.) and partners with Clinical Trial and Transparency colleges
• Develops effective collaborative relationships with other key functional stakeholders
• Participates in department initiatives with other Clinical Regulatory Writing members to formulate writing strategies and standards to be implemented and takes responsibility for execution
• Distills large amounts of clinical and scientific data into essential elements for tabular and graphical display
• Ensures that all documents are written in compliance with relevant clinical and regulatory requirements including continual knowledge of ICH and Health Authority guidance

Preferred Qualifications

Rare disease experience and/or gene therapy experience a plus

Benefits

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans