Managed Services Sr. Consultant
- 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
- 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+ year 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
- 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
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