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

Preferred

• Ability to work independently and collaborate as part of a team
• Effective written and verbal communication skills
• Meticulous attention to detail and quality of work product
• Ability to build and sustain professional relationships
• Ability to lead projects or workstreams
• Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment
• Strong interpersonal skills and professional demeanor
• Ability to meet deadlines
• Ability to provide clear guidance to others

Pay Range

The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $120,200 - $140,000.