Consultant, Regulatory Solutions

Phlexglobal, a Pharmalex Company has a Consultant to serve as Business Analyst and Validation Consultant on projects related to content and data management in Regulatory, Clinical and Quality domains.  Knowledge of Veeva RIM and Submission Vault, Regulatory and content / document management is preferred.
 

• Key responsibilities include 
  • Facilitate working sessions to define future state business processes and gather user and functional requirements from users
  • Develop current and future state process maps and SIPOCs that show inputs, outputs, suppliers and consumers of information
  • Author User / Functional Requirements Specifications; ensure requirements are testable
  • Author UAT/PQ validation test scripts to support user acceptance testing / performance qualification
  • Facilitate UAT testing
  • Document test results and any issues with their resolutions
  • Liaise with technical teams to get test issues resolved
• Education and experience needed
  • College degree preferred
  • 4-7 years experience serving as business and/or validation analyst in Life Sciences GxP regulated space
  • Familiar with Veeva Vault, preferably RIM/Submissions Vault
  • Experience validating Regulatory or R&D content management systems
  • Experience facilitating workshops, defining and documenting business processes and requirements
  • Experience with Systems Development Lifecycles and Validation Methodologies (e.g., GAMP IV)

Phlexglobal, a Pharmalex Company,is an equal opportunity employer and welcomes everyone to join our growing team. At Phlexglobal we make sure that we comply equality, diversity and inclusion in all our offices and prohibit against any discrimination on basis of race, religion, colour, sex, age, martial status or disability status etc.