Ultragenyx

Communications

• Develop and execute the program-level medical communications plan aligned with the global integrated evidence plan, brand strategy, and medical objectives.
• Lead the development and maintenance of the core scientific communications platform and narrative, ensuring consistent interpretation and use of data across medical deliverables.
• Lead the development and maintenance of key medical communications deliverables, including product/program Q&As, and scientific slide decks.
• Support Medical Affairs congress strategy, leading the development of symposia content, congress booth materials, and post-congress scientific summaries.
• Partner with the Publications function to support program-level publication strategy and execution, including contribution to publication plans, alignment of abstracts and manuscripts with evidence priorities, and consistency with the core scientific communications platform and narrative.
• Collaborate with Medical Information and other Medical Affairs colleagues to ensure scientific accuracy and message consistency across standard responses, training materials, and field medical deliverables.
• Ensure all medical communications deliverables are data-current, compliant, and globally aligned.
• Manage external Medical Communications vendors, ensuring quality, compliance, fiscal discipline, and on-time delivery.
• Synthesize scientific insights and competitive intelligence from congresses and external sources into actionable updates for Global Medical Leads and cross-functional partners.
• Serve as a contributor to launch and lifecycle readiness, ensuring Medical Affairs is scientifically prepared for internal and external engagement.

Associate Director, Global Medical Communications

QA Engineer

• Under the direction of the Head of Quality Assurance Japan, lead day-to-day execution of QA activities and contribute to on-time completion.
• Support compliance with internal policies, SOPs, industry standards (GMP/GQP/GDP), and PMDA/MHLW notifications and guidance; support inspection readiness, day-of activities, and drafting post-inspection responses.
• Perform batch disposition (product release) in accordance with Japanese GQP requirements and support communications with regulators on quality matters.
• Oversee domestic product testing and visual inspection results, and promptly report any manufacturing, quality control, or product quality issues identified during batch disposition activities to the General Marketing Compliance Officer, the Head of Quality Assurance Japan, and relevant stakeholders.
• Author, revise, and implement SOPs and quality documents; support operation and continuous improvement of the QMS in line with corporate standards.
• Collaborate with CMC QA, QC, Technical Operations, Regulatory Affairs, and Supply Chain to ensure a safe, uninterrupted, and effective supply of products that meets patient and regulatory expectations.
• Execute and drive quality processes such as change management, deviations/CAPA, product quality complaint investigations, and product recall activities in collaboration with Global Quality.
• Draft and manage Quality Technical Agreements and, ensure their effective implementation, including support for GxP audits and supplier quality oversight of contracted partners such as CMOs, contract testing laboratories, and distributors.
• Provide QA support for artwork management and facilitate Japanese–English communications between domestic partners and global technical team.
• Participate in external collaborations to stay current with domestic policies, practices, and regulatory guidance, and work with CMC Leads and Portfolio Management to support effective project planning and execution. Perform other duties as assigned, as needed.

Senior Manager, Quality Assurance

Compliance

• Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met.
• Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on development program.
• Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks.
• Develop and/or review regulatory documents to ensure that all submissions are of high quality.
• Provide critical review of documents (SOPs, protocols, and reports) related to clinical, nonclinical or manufacturing, as necessary.
• Interface with functional areas (Nonclinical, Clinical, Commercial) to identify and obtain information required for regulatory submissions.
• Prepare/coordinate/file/manage IND/CTAs, annual reports, and information amendments in multiple countries for multiple protocols.
• Prepare/coordinate/file/manage regulatory applications (IND/CTA, NDA/BLA/MAA).
• Interface with global regulatory authorities and consultants.
• Coordinate, prepare for and conduct Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages.
• Maintain knowledge of current global rules, regulations, and guidances governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area.

Manager, Global Regulatory Strategy

Director

• Provide early medical affairs leadership to assigned programs, serving as an active core member of the Program Team and decision-making sub-teams, and contributing to the progression of program milestones
• Demonstrate and apply deep rare disease expertise across assigned programs, actively building and maintaining a global network of therapeutic area experts. Lead insight-generation activities, including scientific advisory boards and steering committees that inform program strategy
• Lead the development of an aligned early-stage Integrated Evidence Generation Strategy for assigned programs, incorporating real world evidence generation, ensuring plans are strategically designed and executed to establish a robust foundational scientific evidence base
• Lead proactive competitive landscape assessments and translate emerging science and therapeutic area dynamics into strategic recommendations for asset positioning
• Establish and lead the Global Medical Sub Team(s), and drive the development and implementation of the medical strategy for assigned pipeline programs, aligned with program objectives and through close collaboration with global medical functions and regional medical leads
• Partner with scientific and medical communications to guide development of the end-to-end scientific communication platform, including the global scientific narrative, ensuring a consistent external global scientific education strategy
• Ensure timely and effective data dissemination by leading publication strategies, congress planning, and scientific education initiatives
• Provide deep disease area and product expertise, ensuring accurate and consistent communication of clinical and scientific data, including sign off in review committees
• Provide guidance, tools, and high-quality compliant training to US field and regional medical affairs teams to elevate consistent scientific exchange, and other internal teams as needed
• Collaborate effectively with clinical development, HEOR, diagnostics, scientific and medical communications and publications, regulatory, market access, commercial, training, and patient advocacy to influence strategic decision making and advance program initiatives

Senior Director, Medical Affairs – Pipeline Lead

Clinical Research

• Supports development, review, and maintenance of study documents such as site instructions, site specific Informed Consent Forms, Lab Manual, Pharmacy Binder, Study Reference Manual, study plans, etc
• Set up and maintain trackers, tools, dashboards, and reports study metrics to support the clinical trials
• Manages one or more small-scope vendors; may support management of complex vendors
• Oversee contracts of assigned vendors including invoicing, purchase order monitoring, and forecasting with study lead oversight
• May be assigned site management responsibilities
• Files study documents in the electronic Trial Master File (TMF), maintain essential documents lists, participation and coordination of TMF completeness reviews, and may serve as the main study contact for Records Management
• Contributes content to team meetings, including Study Management Team meetings

Clinical Trial Specialist

• Manage all programming activities on one or multiple projects/studies across all therapeutic areas, both internally and externally by CROs
• Provide leadership in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage, and align people with the company's strategic objectives
• Work collaboratively with Clinical Operation, Data Management, Global Drug Safety, Regulatory, Project Management, and other functions/staff to meet project deliverables and timelines for statistical data analysis and reporting
• Provide technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers)
• Works with other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate
• Participate in the statistical programming training as appropriate
• Ensure proper implementation of company data standards and industry submission data standards
• Implement standards and project management
• Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports
• Ensure project milestones are met to facilitate decision-making and address business needs

Director, Statistical Programming

• Develop clinical pharmacology plans and drive execution across development pipeline
• Serve as clinical pharmacology subject matter expert and an advisor to senior management
• Represent Clinical Pharmacology on project teams and cross-functional initiatives and in global health authority meetings
• Lead model-informed drug development across development pipeline. Conduct PK and/or PK/PD modeling to inform dosing strategies for development programs. Oversee population PK modeling and exposure response analyses at vendors for regulatory submissions
• Mentor junior-level scientists and may supervise a direct report(s)
• Ensure timely and accurate communication of study results and interpretation to internal drug development teams
• Ensure appropriate quality of documentation for internal studies compatible with requirements for global regulatory submission
• Author clinical pharmacology sections of NDA and/or BLA filings, clinical study reports, protocols, investigator brochures, regulatory responses, and other submissions
• Contribute to clinical pharmacology literature and maintain a current understanding of scientific literature relevant to development programs

Senior Director, Clinical Pharmacology

• Lead the global medical information strategy and operations, ensuring compliant, evidence based responses to unsolicited inquiries from HCPs, patients, and internal teams.
• Oversee creation, review, and maintenance of global standard response letters, FAQs, and medical information resources across marketed and pipeline programs.
• Ensure all materials remain scientifically current, aligned with evolving data, and consistent with regulatory expectations globally.
• Provide strategic direction and quality oversight for outsourced medical information contact center operations.
• Define performance standards, service metrics, and quality management processes for vendor partners.
• Ensure clear triage pathways and timely escalation of complex scientific inquiries to internal experts.
• Monitor inquiry trends to identify emerging knowledge gaps, safety issues, or reputational risks.
• Maintain inspection readiness for all medical information systems, processes, and documentation.
• Serve as Medical reviewer within the Medical–Legal–Regulatory process for assigned assets.
• Provide scientific review of medical information materials, HCP resources, training content, and other scientific communications.
• Ensure all externally facing materials are accurate, balanced, and aligned with current evidence and regulatory guidance.
• Guide the appropriate handling of off label and unsolicited scientific inquiries.
• Govern the scientific accuracy and consistency of all medical information content.
• Partner with Medical Affairs subject matter experts to ensure response materials reflect the company’s scientific narrative.
• Align medical information with publications, field medical materials, and medical education strategies.
• Maintain and govern the MI scientific response library supporting global field medical consistency.
• Represent Medical Information on cross functional product teams for marketed and pipeline assets.
• Collaborate with Pharmacovigilance on identification and triage of safety related information.
• Work closely with Regulatory, Legal, and Compliance to ensure adherence to global guidelines governing scientific exchange.
• Partner with Scientific Communications to ensure coherent scientific messaging across channels.

Director, Medical Information

• Lead the Global Labeling function for Ultragenyx and serve as an internal expert on health agency regulations and guidelines.
• Accountable for oversight of the labeling process at Ultragenyx for all programs in development through commercialization.
• Provide strategic and operational leadership in accordance with business goals and objectives, regulations, and guidelines.
• Guide, develop and author draft labeling text (e.g., USPI, PPI, MedGuide, EU SmPC, EU PIL) to support marketing applications and labeling updates of approved package inserts to support product lifecycle management.
• Ensure labeling strategy is aligned with overall regulatory and program strategy by working closely with the regulatory head, strategy lead and development and project teams.
• Confirm labeling is compliant with US and EU regulatory requirements.
• Develop and maintain CCDS.
• Provides strategic regulatory guidance and expert advice on current labeling requirements, templates, tools and Health Authority-issued guidance across the portfolios globally.
• Chairs the process to obtain labeling approval by Senior Management providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.
• Ability to lead, manage, motivate, mentor and develop a diverse team of Global Labeling Strategy Leads accountable for developing and reviewing and finalizing labeling across all development programs through commercialization.
• Ability to lead, manage, motivate and develop Global Labeling Operations Leads accountable for overseeing packaging and artwork strategies across all commercial product lifecycles.

Senior Director, Global Regulatory Affairs – Labeling

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

• 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.