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Senior Manager Business Solutions, WWRD

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.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

This individual is responsible for supporting WWRD’s (Worldwide Research & Development) technology initiatives through deep understanding of business requirements and desired business outcomes through the utilization of BioMarin’s standard business analysis and project management framework. In collaboration with the WWRD IM Business Solutions Managers, support and review Business Analysis Assessments to ensure BA resources are appropriately assigned for prioritized technology projects. This position will serve as a business systems analysis subject matter expert to ensure high quality standards are applied in support of projects that support a wide variety of validated and non-validated systems of all sizes and complexity supporting WWRD.  

In partnership with the business functional subject matter experts across WWRD, collect, analyze, and document processes to ensure business outcomes are understood in order to identify and support cost benefit analysis of different technology selection options. This includes support of the RFI (Request for Information)/RFP (Request for Proposal) process to ensure all critical requirements are clear and the best vendor/technology to fulfill business needs is selected. This role will also support KTLO, keep the lights on activities, for existing technology, i.e., analyzing upgrade release notes, performing risk analysis and determining test strategy critical to ensuring the business continues to get the most value from our existing technology investments.

This role will also participate in continuous improvement activities to further refine and strengthen our business analysis framework, lessons learned and value realization post project review processes to ensure we are delivering business value as defined in our Project Charters.

Responsibilities

  • Develop and mentor business analyst resources in B.A. best practices such as performing business analysis assessments, risks analysis, gathering requirements, defining business process flows, developing business cases with measurable outcomes using value realization framework, participate in the development of the Total Cost of Ownership analysis and post project value realization reviews.
  • Work with the Business Solutions team to review project candidates, analyze and disposition projects requests for business analysis support and budget needs.
  • Participate on system assessments and implementation Project Teams led by IM (Information Management) Business Solutions Managers or Project Management Office – Project Managers, with other IM functions, (e.g., Infrastructure, Enterprise Architecture), WWRD functions, TOPS (Technical Operations), QA, GCP Compliance and Vendors (as applicable).
  • Translate business requirements into functional and non-functional specifications. Develop functional process flows to further illustrate the business need. Actively manage and communicate changes to specifications.
  • Plan business analysis activities with regard to implementation, ensure the Project Manager includes the activities and task duration in the project timeline.
  • Maintain and continuously improve the business analysis framework; providing best practices, templates to translate business ideas into implementable solutions.
  • Ensure requirements are included for Security, User access (accounts, user privileges), reporting, configuration, audit trail, etc., in addition to functional business requirements.
  • Author, co-author, review and/or maintain project and SDLC related documentation (e.g. Implementation Plan, URS, Validation Plan, Test Scripts, Change Requests, and other change management documentation as called out in the Validation Plan, etc.)
  • Follow up on audit issues and system deviations with QA Validation and Vendor, (IM PMO PM & QA CSV, who may lead deviation investigation). Ensure any issues, deviations are reviewed in the lessons learned exercise to ensure root cause is understood and action taken to mitigate in the future.
  • Support data integrity assessment activities to ensure data and system integrity is maintained while controlling change.
  • Collaborate on problem resolution, team decisions, and project planning.
  • Participate in the development of the Validation Plan. Collaborate with QA and IM CSV to validate that the solution design meets business and functional requirements. Review test plans and testing results while maintaining traceability of end user requirements. Assist end-users in preparation and execution of User Acceptance Testing.
  • Provide consulting to the functional Business Unit, business process owner to ensure change management activities, Training, Training documentation is developed and facilitated for implementation, as well as the plan for the function to support training ongoing.

Experience

  • 6+ years of relevant working experience or 4+ years, experience with a Master’s Degree
  • 2+ years in a supervisory role
  • 5+ years working experience supporting Life Sciences or Pharma Systems utilizing System Delivery Lifecycle documentation using waterfall and agile methodologies.
  • Experience with forecasting, tracking and managing budgets.
  • Experience with applications that are used in Research and Development within the Pharmaceutical/BioTech industry. (e.g. Argus, CTMS, Envision, IxRS, ePRO, Rave EDC, mobile applications, Veeva, applications supporting WWRD functions – e.g., clinical development operations, quality, research, pharmacovigilance, medical affairs, etc..)
  • Strong business analysis skills, operating as part of a team, resource organization, project/task prioritization, planning, and executing projects from vision through implementation.
  • Experience with developing baselines, tracking, maintaining and reporting performance metrics.
  • Ability liaising with stakeholders to elicit, analyze, communicate, and validate requirements for changes or improvement to business processes and information systems.
  • Experience documenting requirements in a validated environment, formalizing business processes and supporting the business in organizational change management efforts.
  • Ability to build strong productive relationships.
  • Strong leadership and communication skills, including an ability to express complex technical concepts in business terms.
  • Excellent collaboration and team building skills with an ability to balance, negotiate and work with a variety of internal and external stakeholders to build strategic partnerships.
  • Ability to simultaneously manage and deliver on multiple competing priorities.
  • Deep knowledge of the clinical drug development process, clinical systems, document management, validation, associated FDA/GCP regulations/guidance, operational aspects and compliance requirements of clinical studies.
  • Strong Presentation Skills

Technical Proficiencies:

  • Demonstrated proficiency in Visio, MS-Excel, MS-Word, MS-Project.
  • Solid understanding of relational databases and reporting tools (e.g. Oracle, SQL server, TrackWise, OBIEE, PowerBI, etc.)
  • HP ALM experience a plus

Education

  • Bachelor's Degree in Software Development, Computer Science, or related field
  • Certification in Business Analysis, IIBA (International Institute of Business Analysis – CBAP (Certified Business Analysis Professional), PMI (Project Management Institute) –PBA (Professional Business Analysis)


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.

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