Senior Principal Consultant - Regulatory Affairs

Woodcliff Lake, NJ

Posted: 02/26/2019 Industry: Business Analyst / Project Manager Job Number: JN -022019-44813
Title: Senior Principal Consultant Regulatory Affairs
Location: Woodcliff Lake, NJ
Duration: Long Term Contract

  • Responsible for designing and implementing data migration strategies for clients of the Regulatory Affairs business.
  • Function as a business and data analyst for migration projects and work with project teams to ensure proper assessment, design, and implementation of Regulatory Information Management (RIM) migration strategies.
  • Work within the client team to develop a winning strategy, develop it with the service line, then present for internal approval and client acceptance.
  • Function as a source of RIM technical and domain expertise and bring value through disciplined project execution.
  • Expected to be focused on the RIM systems and processes used by Regulatory Affairs and understand the issues with migration of data and documents between systems.

  • Work with Project Manager, team, and Business Leaders to assess, design, and execute RIM system implementation, configuration and migration projects
  • Develop and confirm business rules for data mapping and migration
  • Design and implement data migration protocols
  • Identify and mitigate project risks
  • Act in a coaching role to provide training to junior data migration analysts

Minimum Qualifications
  • 7+ years working in Data Analysis or a related field
  • Strong communication and presentation skills
  • Familiarity with IDMP, xEVMPD standards
  • Knowledge of Veeva Vault RIM
  • Knowledge of RIM software vendors and products, MDM and migration
  • Experience with computer systems validation.
  • Experience with data migrations
  • BS degree in science, engineering or related field

Preferred Qualifications
  • Experience with Veeva Vault RIM Migration Optimization initiatives
  • Strong facilitation skills
  • Familiarity with eCTD structure and regulatory submissions types
  • MBA or advanced degree in science, engineering or related field
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