Ultragenyx

Compliance

• Performs moderately complex to non-routine submission formatting activities associated with generating hard copy and electronic submission-ready documents and reports.
• Electronically compiles all components of moderately complex submissions using Lorenz DocuBridge™ and associated publishing tools including but not limited to: eCTDs - National and Centralized Procedures; Post Marketing/Life-cycle Management: Type Ia, Ib and II Variations & Renewals; Orphan Drug Documents, Scientific Advice and PIPs.
• Dispatches submissions through the relevant gateways/portals (e.g. EMA Submissions Gateway and US Gateway and/or other channels) and electronically archives them according to the departmental practices.
• Participates in supporting and promoting current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
• May interface with cross-functional teams and or content authors to discuss routine submission preparation and content.
• May assist and/or provide training to others on software tools used and educating authors in publishing policies and procedures.
• Identifies and records issues that require resolution prior to finalization and liaises with the author responsible to resolve issues. Assists authors in the completion and compilation of regulatory documents to ensure all components are provided and presented in the correct format.
• Exercises judgment within well-defined procedures and practices to determine appropriate action.

Senior Associate, Global Regulatory Operations

Account Manager

• Responsible for the successful commercialization of Ultragenyx products in the assigned territory; accountable for attaining revenue and profitability goals
• Independently analyze market potential, treatment paradigms, decision-making and patient referral patterns in the territory
• Develop, execute and present account plans for key accounts in the territory
• Analyze effectiveness of commercial tactics and monitor changes in the health care system to identify new business opportunities
• Establish sustainable, mutually beneficial relations with opinion leaders and other key stakeholders; engage in regular exchange with peers to share best practices
• Optimize patient care by aligning decision makers involved in relevant decisions (specialists, nurses, pharmacists, payers)
• Develop and execute strategies to identify undiagnosed or misdiagnosed patients
• Support market access on a local level (regions and hospitals) to ensure patients have sustainable access to pharmaceutical innovation
• Field role: Officially documented as working as a member of the Ultragenyx field team, generally interacting with third parties on behalf of Ultragenyx

Key Account Manager

Clinical Operations

• Position Summary: The Director of Clinical Operations is accountable for the operational strategic planning, oversight and delivery for one or more assigned clinical programs.
• Work Model: Remote—Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
• Lead the operational strategy and functional management for one or more clinical trial programs, in accordance with the Clinical Development Plans and program plans
• Accountable for the development and implementation of clinical development program strategies; planning horizon is typically 12-24 months
• Develop and present operational plans to management including risk management and mitigation
• Accountable for the development, implementation and execution of clinical trials within agreed timelines, resources and budgets (including proactive planning and management)
• Provide input on the development of protocols, Case Report Forms, Clinical Study Reports, and regulatory submissions (and all study related documents as needed)
• Represent Clinical Operations on the project teams, such as the Development Sub-Team, Core Teams (as applicable)
• Identify program risks, develop and implement mitigation strategies for assigned programs
• Manage and mentor Clinical Operations personnel
• Oversee vendor interactions (from selection through to close) and being a point of escalation for the operational functional activities and identify key risks. Experience working with internal partners (Vendor Management, Finance etc) in the overarching management of the vendors

Director, Clinical Operations

Financial Planning and Analysis

• Lead the development, implementation, and execution of the enterprise-level annual budget and forecast updates, long-range strategic financial plans (e.g., 5-year plan), and assessing and preparing for alternate scenarios, ensuring alignment with corporate strategy and business objectives • Partner with senior leadership across R&D, Commercial, Technical Operations, and Corporate Functions to develop robust financial models and provide strategic financial input for key decision-making, resource allocation, and investment prioritization • Oversee the preparation and presentation of detailed financial reports, analyses, and dashboards to senior management, the executive leadership team, and the Board of Directors, providing clear, concise, and actionable insights • Provide strong leadership in guiding the FP&A team to deliver high-quality financial analysis and insights that support strategic decision-making • Maximize use of current technology and drive adoption of new advanced technologies as needed • Challenge the status quo and identify opportunities for process optimization and efficiency within financial planning and analysis • Collaborate effectively with Accounting, Treasury, Investor Relations, Business Development, and other functional leads to ensure seamless financial operations and data integrity • Act as a key finance partner to business leaders, providing financial expertise and support for strategic initiatives • Serve as Finance representative to one or more of our project teams, providing analytical and strategic support

Senior Director, Corporate Financial Planning and Analysis

Medical writer

• The Medical Writer is responsible for writing and overseeing the writing of 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

Senior Associate, Global Regulatory Operations

Key Account Manager

Director, Clinical Operations

Senior Director, Corporate Financial Planning and Analysis

Medical Writer (Clinical and Regulatory)