Role Name: Regulatory Information Management (RIM) Consultant
Role Location: UK- Remote
Role Type: Contract
Job Description:
* Provides expertise and leads delivery of projects involving implementation and/or management of Regulatory Information
* Lead the solution design for implementation and use of the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing)
* Lead configuration requirements workshops, design, prototype, configure and document content solutions
* Mentor project team and consultants, helping others improve their consulting skills.
* Expert on life sciences compliance and computer systems validation requirements
* Drives Data & Content Migration into Regulatory Information Management System involves: Source to target data model mapping, Data quality assessment, Recommend / identify / facilitate agreeing on data standards for new RIMS and data migration – naming convention, reference data standards, master data standards
* Identify, lead, and execute data transformation & enrichment activities
* Document E2E Migration Strategy and Associated documentation.
* Drives implementation of new RIMS platform: business requirements elicitation – providing subject matter expertise to drive harmonized, functional requirements strategy with SMEs and stakeholders
* Working with the implementation team to ensure the requirements are adequately implemented supports SMEs & stakeholders with functional & user acceptance testing
* Communicates & collaborates effectively with different groups both on the business & IT side, including senior stakeholders – ability to articulate complex scenarios succinctly and targeted to the group