Regulatory Business Analyst

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