Managed Services Sr. Consultant

Work you’ll do/Responsibilities

• Provide Application Managed Services support for R&D organization for Life Sciences biopharma client.
• 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.
• Configure and administer Generis CARA for regulatory document authoring, structured content management, and eCTD-compliant publishing workflows.
• Collaborate with Regulatory Affairs stakeholders to design and implement submission-ready document templates, dossier structures, and publishing pipelines aligned with ICH CTD/eCTD standards.
• Support integration activities between CARA and upstream/downstream regulatory platforms including Veeva Vault RIM, Lorenz Docubridge, PRISM, or regulatory agency submission gateways.
• Develop functional specifications, configuration documentation, data flow diagrams, and GxP validation artefacts including IQ/OQ/PQ test scripts and traceability matrices.
• Manage and resolve L2/L3 ITSM tickets for regulatory AMS engagements within agreed SLA timelines, using ServiceNow and JIRA for incident tracking and reporting.
• Execute Incident Management, Problem Management, and Change Management activities in line with GxP requirements and ITIL best practices.
• Perform platform administration including user access management, template version control, workflow configuration, and content repository maintenance.
• Conduct root cause analysis (RCA) for recurring platform issues and implement permanent corrective and preventive actions in coordination with platform and Regulatory Affairs teams.
• Participate in go-live readiness activities, cutover planning, hypercare support, and post-implementation review.
• Lead teams comprising consultants and analysts and drive delivery within the regulatory workstream.
• Maintain comprehensive documentation including runbooks, SOPs, functional specifications, validation artefacts, and change management records.

Qualifications Required

• 6+ years with Generis CARA and associated regulatory technology platforms — including requirements gathering, solution design, system configuration, content template development, and user acceptance testing.
• Support integration activities between CARA and upstream/downstream regulatory platforms including Veeva Vault RIM, Lorenz Docubridge, PRISM, or regulatory agency submission gateways.
• Experience working with Regulatory Affairs stakeholders to design and implement submission-ready document templates, dossier structures, and publishing pipelines aligned with ICH CTD/eCTD standards.
• 5+ years conducting root cause analysis (RCA) for recurring platform issues.
• Develop functional specifications, configuration documentation, data flow diagrams, and GxP validation artefacts.
• Manage and resolve L2/L3 ITSM tickets for regulatory AMS engagements including platform administration within agreed SLA timelines, using ServiceNow and JIRA for incident tracking and reporting.
• S/B.E / B.Tech / M.C.A. / M.Sc (CS) degree or equivalent experience.
• Limited immigration sponsorship may be available.
• Ability to travel 10%, on average, based on the work you do and the clients and industries/sectors you serve.
• Role is remote.