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:

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