Ultragenyx

Content Writer

• Participate in the authoring and review of clinical and regulatory documents relating to global marketing applications and clinical trials (eg, clinical study reports, protocols, safety narratives)
• Learn and apply medical writing standards
• Understand the process of distilling large amounts of clinical and scientific data into essential elements for tabular and graphical display
• Perform literature-based research to support writing activities
• Begin to understand global and regional regulatory requirements (eg. ICH E3) and how they impact clinical and regulatory writing
• Liaise with clinical trial transparency colleagues to understand how data from clinical and regulatory documents is disclosed publicly

Intern, Clinical Regulatory Writing

Brand Manager

• Build a scenario framework for anticipated Ph3 readouts (primary/secondary endpoint outcomes, safety profile ranges, subpopulation signals, sensitivity analyses).
• Work with the cross-functional team to design decision trees and activation triggers linked to each scenario, mapping implications for updating all global materials.
• Define insight needs (ad boards, message testing, ATUs, discrete choice/TPP trade-offs, analog analysis) triggered by each scenario.
• Recommend governance cadence (war room / stand-ups, escalation paths, decision logs) for the 0–90 days post-readout window.

MBA Intern, Global Brand Strategy – Neurology

Director

• Serve as Global Medical Lead for LC-FAOD (Dojolvi) and the MPS programs, including MPS VII (Mepsevii) and MPS IIIA (UX111)
• Lead the Global Medical Sub Teams (GMSTs), setting the strategy for the programs, ensuring cross regional alignment, and driving timely execution of annual medical plan
• Guide and oversee prelaunch planning, launch execution, and postlaunch optimization across the globe
• Serve as the strategic medical leader on the Program Core Team and related sub-teams, shaping development, commercialization, and lifecycle strategies. Work decisively to overcome challenges and drive program priorities forward
• Own, develop, and update the Integrated Evidence Generation Plans (IEPs) for all assigned programs ensuring cross functional alignment to address global/regional evidence gaps
• Oversee global Real World Evidence initiatives, including ISTs and collaborative research that inform clinical decision making and regulatory objectives.
• Accountable as the medical affairs lead for Disease Monitoring Programs for LC-FAOD and MPSs, providing strategic medical leadership on all aspects of the study and accountable for leading data generation and publication activities aligned to the IEP
• Lead advisory boards, steering committees, and investigator meetings to gather key insights that inform program strategy and activities
• Provide deep disease area and product expertise, ensuring accurate and consistent communication of clinical and scientific data
• Direct global publication strategy and congress planning activities, ensuring timely, high-impact dissemination of data and other education initiatives
• Lead training and provide strategic guidance and tools to regional medical affairs teams to ensure launch readiness and consistent scientific exchange
• Build and maintain relationships with global KOLs, academic centers of excellence, scientific societies and advocacy groups to inform strategy and amplify scientific reach
• Monitor competitors and landscape changes, translating insights into strategic actions.

Intern, Clinical Regulatory Writing

MBA Intern, Global Brand Strategy – Neurology

Executive Director, Global Medical Lead – LC-FAOD, MPS VII, MPS IIIA