Managed Services Sr. Consultant

The Managed Services Sr. Consultant will provide Application Managed Services support for a Life Sciences biopharma client's R&D organization. This role involves leading and contributing to the delivery of Generis CARA and associated regulatory technology platforms, including requirements gathering, solution design, system configuration, content template development, and user acceptance testing. Responsibilities include configuring and administering Generis CARA for regulatory document authoring and publishing, supporting integrations with other regulatory platforms, developing GxP validation artifacts, managing ITSM tickets, and performing platform administration. The role also involves leading teams and maintaining comprehensive documentation.

What you'd actually do

  1. Lead and contribute to end-to-end delivery for Generis CARA and associated regulatory technology platforms — including requirements gathering, solution design, system configuration, content template development, and user acceptance testing.
  2. Configure and administer Generis CARA for regulatory document authoring, structured content management, and eCTD-compliant publishing workflows.
  3. Support integration activities between CARA and upstream/downstream regulatory platforms including Veeva Vault RIM, Lorenz Docubridge, PRISM, or regulatory agency submission gateways.
  4. Develop functional specifications, configuration documentation, data flow diagrams, and GxP validation artefacts including IQ/OQ/PQ test scripts and traceability matrices.
  5. Manage and resolve L2/L3 ITSM tickets for regulatory AMS engagements within agreed SLA timelines, using ServiceNow and JIRA for incident tracking and reporting.

Skills

Required

  • Generis CARA configuration and administration
  • eCTD-compliant publishing workflows
  • Regulatory document authoring and structured content management
  • Integration with regulatory platforms (e.g., Veeva Vault RIM, Lorenz Docubridge, PRISM)
  • Development of GxP validation artefacts (IQ/OQ/PQ)
  • ITSM ticket management (L2/L3)
  • ServiceNow and JIRA
  • ITIL best practices
  • Functional specifications and documentation
  • Team leadership
  • Independent work and collaboration
  • Effective written and verbal communication
  • Meticulous attention to detail

What the JD emphasized

  • GxP validation artefacts
  • ICH CTD/eCTD standards
  • L2/L3 ITSM tickets
  • regulatory technology platforms