Ultragenyx

Administrative Assistant

• Day-to-day administrative support for the Canadian Vice President & General Manager, and functional leads in Medical Affairs, Market Access, Commercial Operations, Marketing, as well as support for Canadian field teams
• Proactively manage calendar, appointments, and meeting requests through MS Outlook
• Communicate with Canadian leadership, external partners, and internal stakeholders to schedule and set up in-person and virtual meetings
• Participate in special projects and project management work as required by the business
• Contract coordination — support contract-related administrative tasks including document preparation, routing for signatures, and maintaining organized contract files
• Compliantly manage financial processes including purchase order creation and management, invoice payment, budget management and monitoring, and other necessary processes
• Contract creation, review support, lifecycle management, and tracking across internal systems
• Monitor contract timelines, ensuring renewals, expirations, and compliance requirements are proactively addressed
• Track invoices and honoraria and ensure timely payment
• Develop tracking mechanisms in Excel for external expense budgets in alignment with invoices
• Ensure adherence to compliance requirements for payment of honoraria and invoices as well as vendor contract management
• Manage and access necessary online portals/software (iCertis, Oracle, Veeva, OneDrive, Adaptive, SharePoint, Concur, Zoom, Microsoft Teams, etc.) and others as needed
• Conduct regular check-ins with other administrative personnel to optimize activity
• Coordinate interviews, onboarding, and hiring processes

Director

• Build and steward authentic relationships based on respect, understanding and advancing patient focused priorities.
• Embed patient and caregiver perspective and strategic insights from our communities across business strategy, accelerating existing efforts and identifying new opportunities to meaningfully partner across the medicines lifecycle.
• Understand and navigate internal stakeholder engagement, ensuring plans reflect cross functional engagement; facilitating the compliant exchange of complex scientific information related to Ultragenyx areas of research, product development and commercialization.
• Partner closely with Government Affairs, Communications and Regulatory to ensure appropriate patient, caregiver and advocacy leader awareness of, and engagement with, regulatory agencies and policymakers on issues of access and reimbursement.
• Demonstrate leadership within the Patient Advocacy team, across Ultragenyx, and externally with the goal of fostering a best-in-class patient advocacy function.
• Oversee the patient advocacy budget, ensuring company resources are used efficiently and effectively, including the management of external strategic partners.

Senior Director, Patient Advocacy, Engagement

• Identified as an HEOR subject matter expert, able to provide consultation as an internal HEOR subject matter authority to other departments and responsible for developing HEOR strategy and leadership among cross-functional project teams, to mitigate risk and achieve success, across the portfolio of Ultragenyx programs globally
• Generate HEOR data to support clinical development and reimbursement, including design, implementation and analysis of HEOR studies
• Proactively collaborates and demonstrates cross-functional leadership across the organization to facilitate alignment around key HEOR endpoints, outcomes and deliverables and partners closely with internal stakeholders, including medical, clinical development, commercial, market access, endpoint development strategy and management team to identify and develop appropriate HEOR strategy to support global development and reimbursement plans across US, Canada, EMEA, LATAM and APAC regions
• Identify evidence gaps to inform strategic planning and lead development of new evidence strategies to increase understanding of target patient populations of UGX programs and lead development of new evidence generation strategies to achieve market access across global target patient populations of UGX programs
• Review and provide health economics and outcomes research input into clinical development program planning, integrated evidence generation plans, regulatory documents with accuracy and scientific integrity
• Provide leadership through influencing without authority across project teams, internally and externally, can identify & lead cross functional teams for external collaborative research partnerships from project inception thru publication(s) and presentation(s)
• Represent Ultragenyx as Global HEOR subject matter expert at external professional, scientific meetings and forums

Senior Director, Global HEOR

Project Manager

• Partner with Regulatory leads to manage regulatory filing subteams and subteam operations, including the coordination, prioritization, and tracking of regulatory activities associated with Ultragenyx’s development and post-marketing activities
• Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from functional leads, cross-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies
• Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays
• Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory / submission team activities to ensure overall adherence to timelines
• Identify risks and mitigation strategies as well as opportunities for consistency and efficiency across programs in the Ultragenyx portfolio to most effectively support global regulatory pathways
• Develop and maintain program- and portfolio-level reports and dashboards to document and facilitate regulatory milestone and submission communications and ensure that all stakeholders are informed and knowledgeable of activities, progress /delays, and risks / issues
• Facilitate regulatory filing team and working group meetings (schedule, prepare /distribute documentation, prepare agendas and meeting minutes, ensure action item follow-up; meeting leadership and discussion facilitation experience required)
• Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management practices

Director, Regulatory Project Management

Content Writer

• Lead key strategic initiatives within the department including publication strategy, planning, and execution of Ultragenyx products and pipeline publication plans, ensuring alignment with department and company goals.
• Provide leadership within the department by proposing and overseeing new initiatives and capabilities, such as establishing best practices for pubs strategy development and pull-through.
• Interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses and provide publication support and ensure compliant development of company-sponsored publications.
• Ensure smooth and effective document management from start to finish (i.e., generation of a blank document 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, journal and congress submissions).
• Liaise with relevant corporate functions and partner(s), as applicable, to ensure appropriate communication of publications‐related activities including manuscripts and congress abstracts/posters/presentations.
• Uses advanced communication and persuasion strategies to negotiate on behalf of their department or function on strategic matters.
• Contributes to strategic planning for the broader function and support high‐quality execution of Corporate‐wide initiatives.
• Acts as a trusted advisor and recognized technical expert.
• Manage and/or mentor junior medical writers and contractors.
• Support publication budget planning and management.

Senior Director, Medical Writing – Publications

Compliance

• Provides global labeling leadership in support of the development, registration, and life-cycle management of Ultragenyx products for rare diseases.
• Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market labels, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and other reference sources.
• Demonstrate the ability to work in a matrix environment communicating label concepts and key messaging during label development consistent with program strategy and understanding and educating the impact to downstream activities (i.e., for commercial, and promotional educational purposes).
• Build strong collaboration with key internal stakeholders, including Global Regulatory leadership team, Clinical Development, Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, Supply Chain, and other functions to support development of draft label text.
• Interact with the cross functional labeling team (Label Working Group and Label Review Committee) to ensure timely implementation of global labeling changes in local product information that are consistent with the company’s position defined in the CCDS and in compliance with local labeling regulations.
• Prepare, deliver and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input to provide high quality deliverables that meet regulatory standards, and corporate and program milestones. Facilitate LWG/LRC/SME meetings to develop content for label documents including resolution of complex label issues and ability to drive consensus utilizing current standard operating procedures, best practices and/or work instructions including work requests associated with partner companies and vendors.
• Facilitate and lead target label strategies with cross functional labeling team incorporating key messaging aligned with target product profile and thorough understanding of competitive landscape environment. Provide necessary label output for HA interactions (i.e., FDA/EMA/PMDA/HC briefing book, scientific advice, and/or other key submission readiness milestones).
• Manage approved labels in a document label management system to ensure accurate and up-to-date labeling is always available and accessible for global submissions and inspection readiness.
• Contribute to the review and approval of artwork supporting global submissions.
• Implement and maintain a quality control measure during all stages of label development.
• Maintain knowledge base of current global rules, regulations, and relevant guidance (draft or final) governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s).
• Initiate or contribute to local and/or global process and/or system improvements which have a significant impact on business.

Associate Director, Global Regulatory Affairs – Labeling

• Process optimization and execution in providing real world evidence to key stakeholders including patients, providers, researchers, and patient advocacy groups
• Ensure evidence strategy alignment throughout the development cycle for a program and across functions
• Implement best practices for one or more assigned DMPs to monitor key deliverables (e.g. evidence generation, achievement of goals, financial health)
• Provide input on the development of protocols, goals and endpoints tables, case report forms, Integrated Evidence Plans, publications, Steering Committees and other relevant deliverables
• Represent the DMP S&M function on the project teams, such as the Development Sub-Team, Core Teams (as applicable), etc.
• Train and mentor cross-functional personnel working on DMPs as needed

Director, Disease Monitoring Programs, Neurology

• Leads/supports development (including authoring, editing, coordinating reviews, QC, finalization) of clinical and regulatory documents (e.g., protocols, amendments, investigator brochures, clinical study reports, eCTD clinical summaries, briefing books, IRs)
• Drives cross-functional collaboration in the preparation of clinical and regulatory documents, including alignment on content and messaging, effective conduct of roundtable meetings, resolution of feedback/comments
• Distills large amounts of clinical and scientific data into clear, consistent messaging that aligns with program strategy
• Adheres to departmental procedures and practices and applies ICH/GCP/regulatory guidelines and industry standards to document development
• Contributes to developing/implementing processes and best practices within the Clinical and Regulatory Writing department
• Represents Clinical and Regulatory Writing department on various cross-functional teams

Senior Manager, Medical Writing

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.