This role serves as IT focal point for Japan R&D, acting as IT Business Analyst, affiliate level of IT project manager and supporting Japan R&D members for any kinds of IT related initiatives and tasks as IT representative in Japan.
As IT partner for Japan R&D, this role supports key stakeholders in Japan R&D, which includes Pharmacovigilance, Regulatory Affairs, Clinical Operations, PMS, and Clinical development.
The role is to fully understand the business requirements of Japan R&D and operational improvement needs of each stakeholder, which is essential to elicit, analyze, validate, specify, prioritize, and document the business and functional needs of stakeholders in the context of delivering IT services and solutions in the ecosystem as well as supporting the overall strategies.
As a key role in R&D IT team, the Business Analyst role will be responsible for gathering use cases and requirements to shape the initial concepts and projects. S/he will engage business stakeholders to ensure that the business needs are correctly captured and translated into IT solutions. S/he will outline business processes, define the dataflow, analyze options among existing and new tools, and facilitate prioritization and simplification in providing the feasible solutions to achieve short- and long-term business goals. S/he will also be responsible for deliverables per the system development life cycle such as business requirements, functional requirements, traceability matrices, etc.
For this role, multiple IT roles in addition to ITBA need to be covered as affiliate IT, supporting global solution deployment, providing application support for Japan local tools, engaging as ITPM for affiliate level mini-IT project is also required.
Key Responsibilities
- Serving as focal point for the business functions of the affiliates for capturing requirements, following up with the respective functional IT organization and feedback to the local affiliate about solution or alternatives (need BA skills to frame the requirement correctly).
- Implementation and deployment support for large scale IT transformation projects in R&D IT through testing, documentation, issue tracking, data analysis.
- Defining, planning, and leading the execution of locally approved projects (where no regional / global solution can be applied).
- Implementation and deployment support for large scale IT transformation projects in non-Finance G&A-IT ("Corporate Functions": Business Operations, Compliance, HR, Legal & Public Affairs) through testing, documentation, issue tracking, data analysis and change management.
- Provide application support for local tools where no global support is available.
- Identify gaps and inefficiencies in business processes and coordinate with business users in developing to-be processes from as-is processes.
- Coordinating with project managers to help enforce Systems Development Life Cycle standards and required regulations to projects.
- To have a unified global view, aligned with Global IT Strategy, ensuring the provision of architecturally aligned, well integrated business solutions.
- Develop necessary documents, e.g., statement of work, project objectives & metrics, business requirements, use cases, storyboards, functional specifications, systems & end-user documentation.
- Conduct or support trainings for application users and IT application support team.
Qualifications
Required Skills:
- Bilingual (English & Japanese), both written & verbal, Fluent for Japanese and business level for English.
- Business / Process analysis or IT experience in pharmaceutical environment focused on development sciences domain including Pharmacovigilance or R&D/Medical business for 5-10 years.
- Strong analytical skills, including a thorough understanding of how to interpret business needs and translate them into application and operational requirements.
- Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of executives, managers, and subject matter experts.
- Proven ability to drive complex conceptual discussions and develop system requirements. This includes the ability to generate innovative ideas to resolve problems.
- Experience with software categories and related products commonly used by R&D business areas.
- Experience working with global team for IT solutions delivery.
- Basic knowledge/experience of IT collaboration tools such as Microsoft 365.
- Ability to acquire new IT technology as quick learner.
- Ability to operate effectively in a matrix environment as team player.
- Work with minimal guidance; seek guidance on only complex tasks.
- Ability to handle multiple projects/tasks (including a mix of small to complex) at any given time, set priorities, schedule, and meet deadlines.
- Experience of IT solutions in Pharmacovigilance or R&D/Medical space for 5-10 years and knowledge of regulatory guidance and compliance (supporting for GxP and 21 CFR Part 11 regulations).
Nice to Have Skills:
- Program management / Enterprise level of project management
- IT infrastructure skill / Cutting edge IT Technology Skill
- Solution / Application / Web development
- Database / Data analysis / BI skill
- Vendor management
- Experience of work in/for CRO, HCO or any kinds of medical organization
Additional Information
Education
- Bachelor's degree. Master's degree as a plus
- PMP / ITIL / CBAP / ECBA / CCBA / CBAP certification preferred
- TOEIC 800 or any relevant certification
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts.
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