R&D IT Business Analyst Drug Safety
Lexington , Massachusetts
March 14, 2017
Primary Role:

The BA is a bridge between the Business (Need) and the Technology (Solutions). The Business need can be anything about overall business systems (model, process, method etc.) and solutions can be about efficient use of technology (architecture, tool, software application etc.). The BA is required to analyze, transform and ultimately resolve the business problems with the help of technology. The lead BA is an expert of the Drug Safety functional areas and processes.

The BA analyzes the organization need, assesses and documents its processes and systems, and helps define the business model and its integration with technology. The BA leverages appropriate cross-functional expertise from a team of architects, operations managers, strategist, business experts and IT leadership to develop accurate cost, resource and time estimates for both initial development and ongoing support for a proposed solution. The BA is responsible for ensuring requirements, assumptions, dependencies, and risks for potential solutions to technical and business issues are assessed and documented appropriately, for both new and previously established systems. The BA is a key member of the R&D IT team, and is a focal point of customer engagement for initiatives as assigned by the lead from a particular domain of expertise. The BA activity focuses on working with customer groups to analyze business problems and elicitate business requirements. The focus of the analysis is on both business process requirements as well as information or data requirements. The main responsibility is to gather, detail, and document requirements in a way that is useful and meaningful to their business area experts and the technical team implementing the solution. The final outcome of this analysis may result in the selection or customization of a software package, the design or redesign of an existing system, or business process improvement or procedural changes. The Business Analyst interacts with and is accountable to the Project Manager who must ensure that the solution can feasibly be implemented within the expected budget and timelines. The Business Analyst may also provide oversight and contribute to the Service/Support of systems for process they support.

There are five tiers of business analysis in which the BA will participate:

• Strategic planning: In collaboration and alignment with other Shire functions like IT Operations, Enterprise Architectures and IT Business Partners, he/she will responsible for the identify of organization's business needs and having that documented.
• System owner: accountable for system delivery and to identify or approve opportunities for improvement and to resolve issues in current systems
• Business model analysis: to define the organization's policies and technology approaches, and support delivery
• Process design: to standardize the organization's workflows
• System analysis: to interpret business rules and requirements for technical systems and for the creation and update of the technical roadmap

The BA can also act as a consultant/advisor to the business function on demand.

The BA uses tools and technics to perform his activity at the highest level and will leverage the practices documented in the Business Analysis Body of Knowledge® guide or BABOK®. It is recommended also for the BA to be a member of the IIBA (international community of business analysts).


Business Analysis Planning and Monitoring: Planning the tasks and activities for Business Analysis covering stakeholder analysis, managing issues, risks and requirements, and monitoring and reporting on business analysis activities, resolving conflicts, gaining formal approval through governance processes, and tracking requirements through to business case approval. Assessing proposed solutions to help the stakeholders select the solution which best fits their requirements

Elicitation: Working with stakeholders to help them understand their requirements within the scope of a project including eliciting requirements, brainstorming options, analyzing documents, running focus groups, analyzing system interfaces, interviewing stakeholders and subject matter experts, observing real-time activities and work environment, facilitating requirements workshops, reverse engineering existing systems, and collecting input via surveys and questionnaires.

System Owner: Accountable for ensuring overall compliance and validated state of systems as assigned by functional lead. Responsible for data security and integrity for systems as well as inspection readiness. Shire approver as system owner on change documentation or SDLC documentation for new releases. Gather requirements for systems enhancements and work with IT outsourcing partner for delivery. Leverage technical expertise to play role of systems architect and work with enterprise architects to document architecture and obtain ARB approval.

Design the services:
- Formulate and define scope and objectives pertaining to the IT service(s)
- Ensure proper staffing and development of personnel and to implement staffing plans to support organization objectives
- Establish service metrics according to agreed SLA's
- Evaluate, document and publish the procedures, funding, specifications, service levels and other agreements associated with the IT service organization
- Possess and maintain broad technical and business knowledge of all aspects of the service
Provide design input on new services and solutions (e.g. solution architecture, app security, support model)

Requirements Analysis: Working with the whole project team towards defining a solution that will meet the agreed requirements including documenting and analyzing business inputs, defining the support model, modelling the business domain using process diagrams, flowcharts, data models, exploring behavior models (use case, user experience design, storyboards, wireframes, user profiles and user stories), assessing business architecture, performing gap analysis, conducting feasibility studies, , and verifying and confirming requirements.

Education & Experience Requirements:

Bachelor's degree in Computer Science or a related study is required.
A minimum of 10 years relevant IT/Business experience including project scoping, analysis and documentation of business and technical requirements is required.

Experience in the Pharmaceutical industry is essential. Specific experience in Drug Safety is crucial, with good business process skill and a high understanding of the technologies, tools and systems used throughout.
Strong knowledge of IT Computer Systems Validation processes is required.
10+ years of IT consulting and working in complex, global matrix organization is preferred.

Other Job Requirements:
- Domestic travel; limited possible international travel.

About Shire:

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products across our core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine, Hereditary Angioedema, and Oncology.

A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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