Senior Ectd Publisher Jobs (NOW HIRING)

Are you an experienced, passionate pioneer in technology who wants to work in a collaborative environment? As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ideas and collaborate on projects as a consultant without the extensive demands of travel. If so, consider an opportunity with Deloitte under our Project Talent Model. Project Talent Model (PTM) is a talent model that is tailored specifically for long-term, onsite client service delivery.

Recruiting for this role ends on 8/11/2026

Work you'll do/Responsibilities

Managed Services Senior Consultant will 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. Limited immigration sponsorship may be available. The successful candidate would possess these skills:

• 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

The Team 

AI & Engineering leverages cutting-edge engineering capabilities to build, deploy, and operate integrated/verticalized sector solutions in software, data, AI, network, and hybrid cloud infrastructure. These solutions are powered by engineering for business advantage, transforming mission-critical operations. We enable clients to stay ahead with the latest advancements by transforming engineering teams and modernizing technology & data platforms. Our delivery models are tailored to meet each client's unique requirements

Our Industry Solutions offering provides verticalized solutions that transform how clients sell products, deliver services, generate growth, and execute mission-critical operations. We deliver integrated business expertise with scalable, repeatable technology solutions specifically engineered for each sector.

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+ 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

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

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.

You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.

Deloitte is committed to providing reasonable accommodations for people with disabilities. If you require a reasonable accommodation to participate in the recruiting process, please direct your inquiries to the Global Call Center (GCC) at USTalentCICInbox@deloitte.com.

Are you an experienced, passionate pioneer in technology who wants to work in a collaborative environment? As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ideas and collaborate on projects as a consultant without the extensive demands of travel. If so, consider an opportunity with Deloitte under our Project Talent Model. Project Talent Model (PTM) is a talent model that is tailored specifically for long-term, onsite client service delivery.

Recruiting for this role ends on 8/11/2026

Work you'll do/Responsibilities

Managed Services Senior Consultant will 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. Limited immigration sponsorship may be available. The successful candidate would possess these skills:

• 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

The Team 

AI & Engineering leverages cutting-edge engineering capabilities to build, deploy, and operate integrated/verticalized sector solutions in software, data, AI, network, and hybrid cloud infrastructure. These solutions are powered by engineering for business advantage, transforming mission-critical operations. We enable clients to stay ahead with the latest advancements by transforming engineering teams and modernizing technology & data platforms. Our delivery models are tailored to meet each client's unique requirements

Our Industry Solutions offering provides verticalized solutions that transform how clients sell products, deliver services, generate growth, and execute mission-critical operations. We deliver integrated business expertise with scalable, repeatable technology solutions specifically engineered for each sector.

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+ 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

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

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.

You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.

Deloitte is committed to providing reasonable accommodations for people with disabilities. If you require a reasonable accommodation to participate in the recruiting process, please direct your inquiries to the Global Call Center (GCC) at USTalentCICInbox@deloitte.com.