[Hiring] Medical Writer @Ultragenyx Pharmaceutical

Role Description

The Medical Writer is responsible for writing various clinical and regulatory documents. The position works closely with the cross-functional team to ensure the documents are high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The core duties of the medical writing manager are delineated below.

Work Model: Remote - Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

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.

Qualifications

• BS or MS with 0-2+ years in the biotechnology/pharmaceutical industry or advanced degree/PhD in a scientific or medical field.
• 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.
• Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues.
• 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.
• Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design; Project and Visio a plus).
• Rare disease 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.
• Benefits vary by region and country.