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Sr. Business Analyst, Regulatory IT

Company: Biogen
Location: Cambridge
Posted on: June 19, 2022

Job Description:

Job DescriptionAbout This Role As a member of the Regulatory IT team, the Senior IT Business Analyst role will be responsible for gathering use cases and requirements in support of initial concepts and projects. S/he will work with stakeholders to ensure that the stakeholder needs are accurately captured and clear to create a best fit solution. S/he will define data flow and business process diagrams and research the potential use of existing tools. They will also be responsible for deliverables per the system development life cycle such as business requirements, functional requirements, traceability matrices, etc.What You'll Do

  • Work with stakeholders to elicit and validate use cases and requirements, both functional and non-functional for both waterfall and agile projects.
  • Facilitate business requirements gathering process through best practices. Be able to elicit requirements and document them using multiple different requirements writing methodologies.
  • Developing the necessary documentation for IT solutions projects working closely with Project Managers - e.g. statement of work, project objectives & metrics, business requirements, use cases, storyboards, functional specifications, systems & end-user documentation.
  • Work with the technical teams to ensure that business requirements are understood so that plan, build and run can effectively deliver.
  • Draws from experiences to develop solutions to complex problems that require a high degree of ingenuity, creativity and innovation within the boundaries of industry compliance regulation. Identifies and recommends business process improvements
  • Assist in solutions identification, selection, implementation, testing, and working with the IT technical delivery team(s) for translation into solution, whether commercial applications or new development.
  • Ability to articulate complex technical problems and solutions to a wide business audience
  • Serves as a support for training deliverables for stakeholders and technical/functional software support expert during implementations and for prototypes & pilots
  • Understanding of Deviation/CAPA processes
  • Ability to work independently, be self-motivated to accomplish tasks, and have great attention to detailQualifications
    • Thorough knowledge of GxP and 21 CFR Part 11 regulations and guidelines
    • Minimum of 4 - 6 years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies, in the biotech or pharmaceutical industry
    • Experience as a business analyst in a pharmaceutical environment with a focus on development sciences domain including regulatory affairs, submission sciences, regulatory operations or preclinical safety.
    • Well-developed business partnering & collaboration skills, adept at establishing & sustaining effective working relationships, both within & between departments
    • Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors
    • Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner.
    • Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal directionEducation
      • Bachelor's Degree
      • CBAP or PMP certification preferredWhy Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.Additional Information"Diversity is key for the survival of our ecosystem. I believe it is the single most important factor for a balanced flourishing environment where everyone thrives."
        • Guy Hadari - Chief Information Officer- BiogenAll your information will be kept confidential according to EEO guidelines.

Keywords: Biogen, Cambridge , Sr. Business Analyst, Regulatory IT, Professions , Cambridge, Massachusetts

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