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Regulatory Business Analyst

Job ID : 26354

Location : Cambridge, MA

Company Name : QData

Job Type : Contract

Industry : Information Technology

Salary : $60 - $65  per hour

No. of Positions : 1

Required Skills : Regulatory Business Analyst

Benefits : No benefits are available

Job Description :

    Responsibilities & Duties:

    • The key activities for this position include:
    • Lead/Co-Lead requirements elicitation sessions
    • Develop process knowledge to translate to business and technical requirements
    • Documentation of business processes and use cases
    • Author of SDLC deliverables for review
    • When required, support complex data migration activities, including Excel data mapping and repeated load processing activities
    • Provide appropriate technical/functional software support throughout the life of the project
    • Assist in testing preparation and implementation of new application
    • Support development of training materials and facilitation of end user training sessions 
    • Contribute to the creation of operational support documentation
    • Determine systems retirement/data archiving requirements and execute via standard processes, as needed
    • Complete other ad hoc tasks requested of Principal Business Analyst

    Required Qualifications:

    • 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.
    • 8+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies.
    • 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 direction.
    • Familiarity with GxP, CFR 21 Part 11 and systems validation.
    • Education: a Bachelor’s degree is required

    Desired Qualifications:

    • Life Sciences, Biotech or pharmaceutical industry experience preferred.
    • Regulatory and/or Parexel Insight Manager knowledge a plus.

    Mandatory Skills:

    • Business Analyst with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies,
    • Familiar with GxP, CFR 21 Part 11 and systems validation
    • strong RIM Tracking and Publishing


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