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Business Solutions Manager/ Sr.Manager, R&D Applications, RIM

Location San Rafael, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

Summary

The role of the Business Solutions Manager, R&D Applications, RIM – (Regulatory Information Management) is critical to ensure successful development, delivery, and support of Information Management strategies which emphasize the IM organization’s leadership role in “managing information” to enable business stakeholders the ability to author regulatory submissions content and manage the regulatory submissions process.

This role serves as the Global Application Owner for all applications supporting the Veeva RIM Suite; including maintaining application roadmaps, providing lifecycle management, coordinating support, process change, and overall business systems analysis for the regulatory information management. The role will be accountable for the Total Cost of Ownership and Value Realized from these applications. The role will work collaboratively with the Global IM Team supporting R&D, Regulatory, and Technical Operations functions to assure design and deployment of scalable, supportable solutions that fit with the Veeva RIM platform and governance.

Will directly supervise consultants / managed service resources dedicated to capturing and clarifying the Business need, supporting system related process improvement, the scoping and potential cross functional impact.  With proactive communication to personnel, understand the critical processes and their system implications. This includes analyzing current system solutions and opportunities for further system development/modification to maximize value from current systems, and develop strategies to replace them with more suitable solutions not yet part of the RIM application portfolio.

Will oversee technical resources during solution implementation and will be responsible for the overall delivery of the solution including: Design Review, Build Review, User Acceptance Testing, partnering with the business to develop the change management strategy, and defining the post go-live support structure.

May be directly involved in investigating and resolving high priority / complex / advanced production issues.

Responsibilities

  • In partnership with Regulatory, R&D, Information Management, and Technical Operations functions, define and maintain global application governance and prioritization processes for existing RIM technology, i.e, BioMarin’s RIM Applications.
  • Partner with business stakeholders to identify business challenges and related solutions
  • Develop, maintain and communicate an intimate understanding of Business strategies and champion the ongoing maintenance of the Regulatory Technology roadmap
  • Facilitate communication and maintain bi-directional awareness of R&D / Regulatory and Global IM initiatives
  • Collaborate with the Global IM Team to maintain and improve best practices and standardize processes across all IM resources supporting the Veeva Platform. Partner with other IM Business Solutions functions to share knowledge and drive continuous improvement across the Veeva Platform.
  • Identify opportunities for operational efficiency through innovation and automation
  • Measure and manage the Total Cost of Ownership (TCO) and Value Realization (VR) of applications
  • Analyze and evaluate systems for optimization or operational efficiency
  • Lead continuous improvement effort assessing current use and intended use of the Veeva RIM suite and Submissions application
  • Capable of assessing end-to-end business processes to provide effective global solutions
  • Partner with Veeva to define additional opportunities at BioMarin and drive those opportunities to the platform, further enabling the Enterprise Veeva Platform model.
  • Application Lifecycle Management – Develop and support a fully aligned and business-approved release management cycle incorporating Release impact assessments.

Operational/Tactical Responsibilities:

  • Directly supervise resource(s) providing Business Analysis, Solution Design & Delivery, and Support.
  • Support execution of Veeva RIM projects
  • Participate in and / or lead planning discussions for system / process roadmaps, Annual budget planning, solution / market analysis in support overall enterprise application management
  • Vendor Management: Software license negotiation and management of consulting service providers.
  • Perform System Analysis and Business Analysis activities (i.e. process, solution design)
  • Manage technical consultants to design, build, test, and implement new solutions
  • Partner with application support team to resolve user issues
  • Assist with prioritization and coordination of RIM related enhancement requests.
  • Participate on change control boards and design review committees
  • Perform fit / gap assessments and providing solution options with impact assessments
  • Identify areas for business process improvement and efficiencies; make recommendations to improve existing processes or system functionality
  • Work with external application developers or system integrators to implement functional and reporting applications

Education & Experience

  • 6+ years, experience in supporting enterprise applications
  • 4+ years, experience in Regulatory Information Management systems. Ideally, some of which would be with Veeva’s RIM Suite (e.g. Submissions) and other regulatory applications such as Insight for Publishing, Insight for Registration, Lorenz, Litera DocXtool, Intagras GDT for Labeling.
  • Working knowledge of Regulatory Operations processes (submission preparation, document management, submission publishing, product registration)
  • Experience in computer system validation practices and the principles supporting Life Science or Pharma companies
  • Experience forecasting and managing budgets
  • Experience measuring Value Realized from software applications
  • Experience managing software and service vendors
  • Very strong interpersonal and communication skills and ability to interact effectively with all levels of management
  • Demonstrated ability to build strong working relationships with a cross-functional team and ability to influence others and achieve results
  • Ability to simultaneously manage and deliver on multiple competing priorities
  • Preferred experience:
    • Experience in Life Science or Pharma, supporting regulatory systems that support submissions such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, etc.).
    • End-user and/or Administrator experience with Regulatory Operations software
  • Understanding of SaaS/Cloud solutions and technology

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

~BIO

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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