Medical Writer

Summary

Join Ultragenyx, a biopharmaceutical company focused on rare disease medicine, as a Medical Writer. You will be responsible for writing and overseeing clinical and regulatory documents, collaborating with cross-functional teams to ensure high quality and timely completion. This remote position requires strong medical writing, editing, and clinical development experience, including experience with eCTD/NDA submissions. The ideal candidate will possess exceptional communication and organizational skills, and the ability to work both independently and collaboratively. Ultragenyx offers a competitive salary and benefits package, including generous vacation time, volunteer days, long-term incentives, employee wellbeing benefits, and professional development opportunities.

Requirements

• BS, MS, or doctorate in a scientific or medical field
• Two+ years in the biotechnology/pharmaceutical industry preferred
• 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
• Proven ability to implement medical writing processes and standards
• Exceptional oral and written communication skills
• Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues
• Flexible; adapts work style to meet organization needs
• Strong organizational abilities and experience in a multitasking environment
• Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
• Dedication to quality and reliability
• Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design; Project and Visio a plus)
• Ability to build and maintain effective partnerships, both internally and externally

Responsibilities

• Write, edit, or collaborate on development of clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)
• Ensure smooth and effective document management from start to finish (i.e., from template to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving)
• Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives as required and ensure adherence to standards
• Distill large amounts of clinical and scientific data into essential elements for graphical display
• Partnering with lead author, oversee document review and comment resolution meetings with cross-functional teams
• Formulate key messages from clinical study data
• Perform literature-based research to support writing activities
• Develop and maintain templates and outlines for key documents

Preferred Qualifications

Rare disease experience or a strong understanding of metabolic bone disease 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