Lead Business Analyst, Vaccines IT応募後で応募 求人ID R0029187 掲載日 06/15/2021 Location:Boston, Massachusetts
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Lead Business Analyst, Vaccines IT.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Lead Business Analyst working on the Vaccines IT team, you will be empowered to partner with business process owners within Vaccines and drive IT System implementation/enhancement projects to support the business. In this role, you will contribute to Takeda’s mission by supporting Vaccines Regulatory, and later scope to include all pharmaceutical development functional areas.
- Partner with business process owners within Vaccines to understand business needs and drive capability and IT system implementation/enhancement projects to support the business. Initial focus supporting Vaccines Regulatory, later scope will include all pharmaceutical development functional areas.
- Provides leadership to the analysis of complex business problems and manages business requirements within area of responsibilities.
- Leads development of scope and business priority-setting for change initiatives of large size and complex system implementations.
- Proactively identifies technology solutions and influences business objectives, taking into account the implications of change on the organization and all stakeholders.
- Partner with leadership and business process owners to understand informatics needs, plan for and lead IT projects that deliver new business capabilities.
- Leverage technology skills and business process knowledge to support the Takeda Vaccines Business Unit (VBU) Regulatory Affairs organization.
- Assist in the development of platform/capability roadmaps, system architecture and IT support models
- Lead cross functional system implementation project teams delivering quality solutions with speed and agility while adhering to the software development life cycle (SDLC) documentation, validation, and change management requirements.
- Maintain oversight and quality of technical deliverables, project contractors and vendor resources
- Understand and influence vendor solutions/roadmaps and industry technology advancements along with evolving regulatory requirements. Actively shares information with customers and peers
- Communicates effectively with stakeholders at all levels maintaining rich client relationships
- Supports VBU IT demand management and budget planning activities
- Supports global IT infrastructure strategies and initiatives
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelors degree and 10+ years of relevant experience or Masters Degree and 8+ years relevant experience within the Pharmaceutical industry or the drug development business.
- Demonstrated knowledge and experience supporting Development and Regulatory business processes
- Current on emerging technologies used to streamline and flawlessly run Global Development Operations processes, especially focused on leveraging technology to Regulatory Affairs
- Embraces Design Thinking, Lean Startup approaches, and Agile principles. Expert on Agile scrum delivery, experience coaching team members, familiar with toolsets such as Jira, Confluence, Jira Align.
- Experience with Regulatory Information Management solutions (Veeva RIM), Collaborative Workspaces, Viewer and Validation tools as well as related Development and Quality Systems (eTMF, CTMS, QMS)
- Development experience with Tableau and/or PowerBI visualization tools
- Good understanding of GxP regulations and regulated computer system support, IT SDLC and software validation processes
- Experience in IT Program Management and business analysis
- Understanding of technical IT issues to enable discussions with internal and external technical specialists
- Ability to be self-directed and work independently within the framework of the IT organization.
- Keenly developed business partnering & collaboration skills, adept at establishing & sustaining effective working relationships;
- Ability to operate effectively in a matrix environment; team player.
- Fluent in English.
- Experience designing, deploying and maintaining cloud-based GxP applications
- Experience with PleaseReview, GlobalSubmit, Medidata CTMS, AWS, Sharepoint, and Box document management
- Experience working with solutions delivery teams such as corporate IT infrastructure/architecture, applications development & integration, and support
- Experience supporting heavily outsourced organizations and working with CROs/CDMOs.
- Experience defining and maintaining data transfer and/or data integration mechanisms in a hosted systems architecture to support an outsourced development model
- Veeva Vault Admin
- PMI Agile Certified Practitioner (PMI-ACP)
- SAFe Agilist (SA)
- Project Management (PMP, Prince II or equivalent).
- Business Analysis (IIBA or PMI)