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Director, Global Regulatory Information Systems

Company: Ultragenyx Pharmaceutical
Location: Novato
Posted on: April 5, 2021

Job Description:

Director, Global Regulatory Information Systems Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease.-- Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission - to make a difference in our patients' lives. Come join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include WebEx video discussions, interviews & onboarding. #ultrapassionate The Director of Global Regulatory Information Systems leads the regulatory information management (RIM) program for Ultragenyx globally (Ultragenyx Pharmaceutical (UGX) and Ultragenyx Gene Therapy (UGT)). This individual is a strategist, collaborator, and confident leader that understands the complexities of RIM and is passionate about driving and delivering meaningful changes to support our current and future RIM goals. The position requires a solid understanding of Regulatory Affairs/Operations and extensive hands-on expertise in Regulatory specific technology (e.g. InSight Publisher/Viewer and Veeva Vault RIM), excellent business analysis and project management skills. This individual collaborates with Global Regulatory Affairs (UGX/UGT) and other cross-company functions in driving the development and refinement of our existing and desired global processes to support a robust RIM program to take Ultragenyx into the future. This individual will report to the Executive Director, Regulatory Operations. This role requires outstanding interpersonal, communication, leadership and collaboration skills along with the ability to synthesize information and translate it into meaningful strategy. Responsibilities:

  • Translate global RIM-related regulations into meaningful business requirements and solid action plans to support current and future RIM initiatives over the next 3-5 years.
  • Provides leadership and subject matter expertise on Regulatory systems projects.
  • Responsible for the execution and delivery of Regulatory systems projects (new implementations, mergers, upgrades, and enhancements).
  • Responsible for the daily business administration of Regulatory systems (e.g. SharePoint, InSight Publisher/Viewer and Veeva Vault RIM), including (but not limited to) user management, training, issue escalation and resolution and working with IT and third-party providers.
  • Drive the development and/or refinement of business process maps by working cross-functionally to identify future state process requirements and documentation to support the desired future state.
  • Responsible for driving the documentation and revision of all Regulatory Affairs systems SOPs, and work instructions (WIs) for applicable systems.
  • Drive the development and updates for training presentations and other relevant training material for Regulatory systems.
  • Works collaboratively with IT business partners in the management of enterprise systems, the development and adherence to data standards.
  • Maintain a robust data foundation across Global Regulatory Affairs/Operations processes and systems in order to make information accessible and connected to support regulatory business cases.
  • Partner with vendors and/or IT business partners in keeping abreast of technology trends and applicability to business needs.
  • Collaborates on technology initiatives and applies leadership skills by working in a global environment with business colleagues across functional teams including (but not limited to) Clinical, BioStats, DSPV, and CMC.
  • Promote a culture of quality, operational excellence and continuous improvement, supporting company growth.
  • May manage/mentor direct reports and contractors. Requirements:
    • Excellent technical understanding and proven, hands-on experience in technologies such as SharePoint, eCTD Publishing Tools (InSight Publisher/Viewer), Veeva Vault RIM, and off-the-shelf and plug-in software such and StartingPoint Templates, DXC Toolbox that supports the global Regulatory business and have solid understanding in developing Regulatory requirements, such as IDMP.
    • Highly collaborative team player that can communicate clearly to both technical and non-technical stakeholders to understand challenges and drive for win-win outcomes.
    • Exceptional problem solving skills and ability to formulate innovative solutions that demonstrate both strategic and tactical thinking.
    • Demonstrated ability to organize, prioritize, and execute on projects to completion.
    • Proven experience in leading organizational change and influencing others.
    • Strong knowledge of control and management of regulatory-focused content, throughout the product lifecycle stages, SDLC methodologies and CFR Part 11 and Annex 11 compliance.
    • Proven experience in staff management, coaching and career development.
    • Excellent judgment and interpersonal skills, consensus and relationship building
    • Outstanding presentation skills and professional presence.
    • Veeva Vault Platform Administrator certification, highly desirable.
    • Bachelor's degree (within a life sciences subject or information technology) with 8+ yrs experience in Regulatory or Regulatory technology or equivalent with extensive knowledge of global regulatory industry initiatives and direction.
    • Expert in the use of Microsoft Office Suite (Word, Excel, Power Point, Project, Visio). #LI-TR1 Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact--Talent Acquisition--by calling:--(415) 483-8800--or by--emailing--us . For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed .

Keywords: Ultragenyx Pharmaceutical, Novato , Director, Global Regulatory Information Systems, IT / Software / Systems , Novato, California

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