Associate Systems Analyst - docuBridge
Amgen
Associate Systems Analyst - docuBridge
Job Description
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
What you will do
- Assist in the implementation, operations and validation testing of Lorenz DocuBridge Suite, ensuring the solution meets both global and regional regulatory requirements (e.g., eCTD & NeeS).
- Collaborate with multi-functional partners including Regulatory Affairs, Quality Assurance, IT Security, and vendor teams to gather detailed business requirements and translate them into scalable, compliant technical solutions.
- Support the team in defining and managing project plans, timelines, resource allocation, and key landmarks to ensure end-to-end project execution - from system assessment, procurement, configuration, validation, launch, to post-production support.
- Assist in driving validation and compliance readiness by developing validation plans, IQ/OQ/PQ protocols, and related documentation as per GXP, 21 CFR Part 11 guidelines.
- Ensure regulatory submission readiness by enabling structured document authoring workflows, lifecycle management, and integration with content sources such as Regulatory Veeva RIM.
- Work on user access controls, role-based privileges, and audit trail configurations to ensure system integrity and security are maintained.
- Support the change control process for the submission system by aligning with ITIL standards and ensuring traceability for all updates, patches, and configuration changes.
- Support team to Develop training materials and conduct hands-on user training to onboard regulatory users and business owners, ensuring effective adoption of the system.
- Monitor production performance and work with business team and vender partner to solve issues, ensuring timely resolution of incidents with minimal impact on business continuity.
What we expect of you
- Bachelor’s degree and 2 to 6 years of relevant experience
- Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
- Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
- Possess strong knowledge of information systems and network technologies.
- Experience on working with Submission tools.
- Experience in Systems Development Life Cycle (SDLC), including requirements gathering, design, data analysis, testing, and change control
- Experienced in relational database (e.g. Oracle, PostgreSQL) and writing SQL
- Knowledge of one or more general programming languages, including but not limited to: Java or Python
- Knowledge of API integrations such as MuleSoft & Databricks
- Experience working in cloud services such as AWS
- Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11 and GxP Compliance
- Knowledgeable of new technologies for Machine Learning and Natural Language Processing (NLP) and Natural Generation Language (NLG)
- SAFe® for Teams certification (preferred)
- Excellent analytical and problem-solving skills with a good attention to detail
- Ability to deal with ambiguity and work effectively with global, virtual teams
- High degree of initiative and self-motivation
- Ability to influence and hold team members accountable to commitments
Must-Have Skills
- Experience in applying technology standard process methodologies such as Scaled Agile (SAFe) and ITIL.
- Hands-on experience with Lorenz DocuBridge
- Experience with structured regulatory submission solutions
- Experience in validation testing and user grievance resolution
- Knowledge of regulatory requirements (e.g., eCTD & NeeS)
- Project management skills including timelines and resource allocation
- Development of validation plans, IQ/OQ/PQ protocols
- Structured document authoring workflows and lifecycle management
- Integration with content sources such as Regulatory Veeva RIM
- User access controls, role-based privileges, audit trail configurations
- Change control process aligning with ITIL standards
- Developing training materials and conducting user training
- Monitoring production performance and incident resolution
- Relational database (e.g. Oracle, PostgreSQL) and SQL
- Programming languages: Java or Python
- API integrations: MuleSoft & Databricks
- Cloud services: AWS
- Computer Systems Validation: FDA 21 CFR Part 11 and GxP Compliance
- Machine Learning, Natural Language Processing (NLP), Natural Generation Language (NLG)
What you can expect of us
- Competitive benefits
- Collaborative culture
- Support for professional and personal growth and well-being
- Competitive and comprehensive Total Rewards Plans aligned with local industry standards
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
12,000 - 25,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Experience in applying technology standard process methodologies such as Scaled Agile (SAFe) and ITIL.intermediate
- Hands-on experience with Lorenz DocuBridgeintermediate
- Experience with structured regulatory submission solutionsintermediate
- Experience in validation testing and user grievance resolutionintermediate
- Knowledge of regulatory requirements (e.g., eCTD & NeeS)intermediate
- Project management skills including timelines and resource allocationintermediate
- Development of validation plans, IQ/OQ/PQ protocolsintermediate
- Structured document authoring workflows and lifecycle managementintermediate
- Integration with content sources such as Regulatory Veeva RIMintermediate
- User access controls, role-based privileges, audit trail configurationsintermediate
- Change control process aligning with ITIL standardsintermediate
- Developing training materials and conducting user trainingintermediate
- Monitoring production performance and incident resolutionintermediate
- Relational database (e.g. Oracle, PostgreSQL) and SQLintermediate
- Programming languages: Java or Pythonintermediate
- API integrations: MuleSoft & Databricksintermediate
- Cloud services: AWSintermediate
- Computer Systems Validation: FDA 21 CFR Part 11 and GxP Complianceintermediate
- Machine Learning, Natural Language Processing (NLP), Natural Generation Language (NLG)intermediate
Required Qualifications
- Bachelor’s degree and 2 to 6 years of relevant experience (experience)
- Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. (experience)
- Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. (experience)
- Possess strong knowledge of information systems and network technologies. (experience)
- Experience on working with Submission tools. (experience)
- Experience in Systems Development Life Cycle (SDLC), including requirements gathering, design, data analysis, testing, and change control (experience)
- Experienced in relational database (e.g. Oracle, PostgreSQL) and writing SQL (experience)
- Knowledge of one or more general programming languages, including but not limited to: Java or Python (experience)
- Knowledge of API integrations such as MuleSoft & Databricks (experience)
- Experience working in cloud services such as AWS (experience)
- Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11 and GxP Compliance (experience)
- Knowledgeable of new technologies for Machine Learning and Natural Language Processing (NLP) and Natural Generation Language (NLG) (experience)
- SAFe® for Teams certification (preferred) (experience)
- Excellent analytical and problem-solving skills with a good attention to detail (experience)
- Ability to deal with ambiguity and work effectively with global, virtual teams (experience)
- High degree of initiative and self-motivation (experience)
- Ability to influence and hold team members accountable to commitments (experience)
Responsibilities
- Assist in the implementation, operations and validation testing of Lorenz DocuBridge Suite, ensuring the solution meets both global and regional regulatory requirements (e.g., eCTD & NeeS).
- Collaborate with multi-functional partners including Regulatory Affairs, Quality Assurance, IT Security, and vendor teams to gather detailed business requirements and translate them into scalable, compliant technical solutions.
- Support the team in defining and managing project plans, timelines, resource allocation, and key landmarks to ensure end-to-end project execution - from system assessment, procurement, configuration, validation, launch, to post-production support.
- Assist in driving validation and compliance readiness by developing validation plans, IQ/OQ/PQ protocols, and related documentation as per GXP, 21 CFR Part 11 guidelines.
- Ensure regulatory submission readiness by enabling structured document authoring workflows, lifecycle management, and integration with content sources such as Regulatory Veeva RIM.
- Work on user access controls, role-based privileges, and audit trail configurations to ensure system integrity and security are maintained.
- Support the change control process for the submission system by aligning with ITIL standards and ensuring traceability for all updates, patches, and configuration changes.
- Support team to Develop training materials and conduct hands-on user training to onboard regulatory users and business owners, ensuring effective adoption of the system.
- Monitor production performance and work with business team and vender partner to solve issues, ensuring timely resolution of incidents with minimal impact on business continuity.
Benefits
- general: Competitive benefits
- general: Collaborative culture
- general: Support for professional and personal growth and well-being
- general: Competitive and comprehensive Total Rewards Plans aligned with local industry standards
Tags & Categories
Associate Systems Analyst - docuBridge
Amgen
Associate Systems Analyst - docuBridge
Job Description
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
What you will do
- Assist in the implementation, operations and validation testing of Lorenz DocuBridge Suite, ensuring the solution meets both global and regional regulatory requirements (e.g., eCTD & NeeS).
- Collaborate with multi-functional partners including Regulatory Affairs, Quality Assurance, IT Security, and vendor teams to gather detailed business requirements and translate them into scalable, compliant technical solutions.
- Support the team in defining and managing project plans, timelines, resource allocation, and key landmarks to ensure end-to-end project execution - from system assessment, procurement, configuration, validation, launch, to post-production support.
- Assist in driving validation and compliance readiness by developing validation plans, IQ/OQ/PQ protocols, and related documentation as per GXP, 21 CFR Part 11 guidelines.
- Ensure regulatory submission readiness by enabling structured document authoring workflows, lifecycle management, and integration with content sources such as Regulatory Veeva RIM.
- Work on user access controls, role-based privileges, and audit trail configurations to ensure system integrity and security are maintained.
- Support the change control process for the submission system by aligning with ITIL standards and ensuring traceability for all updates, patches, and configuration changes.
- Support team to Develop training materials and conduct hands-on user training to onboard regulatory users and business owners, ensuring effective adoption of the system.
- Monitor production performance and work with business team and vender partner to solve issues, ensuring timely resolution of incidents with minimal impact on business continuity.
What we expect of you
- Bachelor’s degree and 2 to 6 years of relevant experience
- Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
- Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
- Possess strong knowledge of information systems and network technologies.
- Experience on working with Submission tools.
- Experience in Systems Development Life Cycle (SDLC), including requirements gathering, design, data analysis, testing, and change control
- Experienced in relational database (e.g. Oracle, PostgreSQL) and writing SQL
- Knowledge of one or more general programming languages, including but not limited to: Java or Python
- Knowledge of API integrations such as MuleSoft & Databricks
- Experience working in cloud services such as AWS
- Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11 and GxP Compliance
- Knowledgeable of new technologies for Machine Learning and Natural Language Processing (NLP) and Natural Generation Language (NLG)
- SAFe® for Teams certification (preferred)
- Excellent analytical and problem-solving skills with a good attention to detail
- Ability to deal with ambiguity and work effectively with global, virtual teams
- High degree of initiative and self-motivation
- Ability to influence and hold team members accountable to commitments
Must-Have Skills
- Experience in applying technology standard process methodologies such as Scaled Agile (SAFe) and ITIL.
- Hands-on experience with Lorenz DocuBridge
- Experience with structured regulatory submission solutions
- Experience in validation testing and user grievance resolution
- Knowledge of regulatory requirements (e.g., eCTD & NeeS)
- Project management skills including timelines and resource allocation
- Development of validation plans, IQ/OQ/PQ protocols
- Structured document authoring workflows and lifecycle management
- Integration with content sources such as Regulatory Veeva RIM
- User access controls, role-based privileges, audit trail configurations
- Change control process aligning with ITIL standards
- Developing training materials and conducting user training
- Monitoring production performance and incident resolution
- Relational database (e.g. Oracle, PostgreSQL) and SQL
- Programming languages: Java or Python
- API integrations: MuleSoft & Databricks
- Cloud services: AWS
- Computer Systems Validation: FDA 21 CFR Part 11 and GxP Compliance
- Machine Learning, Natural Language Processing (NLP), Natural Generation Language (NLG)
What you can expect of us
- Competitive benefits
- Collaborative culture
- Support for professional and personal growth and well-being
- Competitive and comprehensive Total Rewards Plans aligned with local industry standards
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
12,000 - 25,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Experience in applying technology standard process methodologies such as Scaled Agile (SAFe) and ITIL.intermediate
- Hands-on experience with Lorenz DocuBridgeintermediate
- Experience with structured regulatory submission solutionsintermediate
- Experience in validation testing and user grievance resolutionintermediate
- Knowledge of regulatory requirements (e.g., eCTD & NeeS)intermediate
- Project management skills including timelines and resource allocationintermediate
- Development of validation plans, IQ/OQ/PQ protocolsintermediate
- Structured document authoring workflows and lifecycle managementintermediate
- Integration with content sources such as Regulatory Veeva RIMintermediate
- User access controls, role-based privileges, audit trail configurationsintermediate
- Change control process aligning with ITIL standardsintermediate
- Developing training materials and conducting user trainingintermediate
- Monitoring production performance and incident resolutionintermediate
- Relational database (e.g. Oracle, PostgreSQL) and SQLintermediate
- Programming languages: Java or Pythonintermediate
- API integrations: MuleSoft & Databricksintermediate
- Cloud services: AWSintermediate
- Computer Systems Validation: FDA 21 CFR Part 11 and GxP Complianceintermediate
- Machine Learning, Natural Language Processing (NLP), Natural Generation Language (NLG)intermediate
Required Qualifications
- Bachelor’s degree and 2 to 6 years of relevant experience (experience)
- Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. (experience)
- Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. (experience)
- Possess strong knowledge of information systems and network technologies. (experience)
- Experience on working with Submission tools. (experience)
- Experience in Systems Development Life Cycle (SDLC), including requirements gathering, design, data analysis, testing, and change control (experience)
- Experienced in relational database (e.g. Oracle, PostgreSQL) and writing SQL (experience)
- Knowledge of one or more general programming languages, including but not limited to: Java or Python (experience)
- Knowledge of API integrations such as MuleSoft & Databricks (experience)
- Experience working in cloud services such as AWS (experience)
- Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11 and GxP Compliance (experience)
- Knowledgeable of new technologies for Machine Learning and Natural Language Processing (NLP) and Natural Generation Language (NLG) (experience)
- SAFe® for Teams certification (preferred) (experience)
- Excellent analytical and problem-solving skills with a good attention to detail (experience)
- Ability to deal with ambiguity and work effectively with global, virtual teams (experience)
- High degree of initiative and self-motivation (experience)
- Ability to influence and hold team members accountable to commitments (experience)
Responsibilities
- Assist in the implementation, operations and validation testing of Lorenz DocuBridge Suite, ensuring the solution meets both global and regional regulatory requirements (e.g., eCTD & NeeS).
- Collaborate with multi-functional partners including Regulatory Affairs, Quality Assurance, IT Security, and vendor teams to gather detailed business requirements and translate them into scalable, compliant technical solutions.
- Support the team in defining and managing project plans, timelines, resource allocation, and key landmarks to ensure end-to-end project execution - from system assessment, procurement, configuration, validation, launch, to post-production support.
- Assist in driving validation and compliance readiness by developing validation plans, IQ/OQ/PQ protocols, and related documentation as per GXP, 21 CFR Part 11 guidelines.
- Ensure regulatory submission readiness by enabling structured document authoring workflows, lifecycle management, and integration with content sources such as Regulatory Veeva RIM.
- Work on user access controls, role-based privileges, and audit trail configurations to ensure system integrity and security are maintained.
- Support the change control process for the submission system by aligning with ITIL standards and ensuring traceability for all updates, patches, and configuration changes.
- Support team to Develop training materials and conduct hands-on user training to onboard regulatory users and business owners, ensuring effective adoption of the system.
- Monitor production performance and work with business team and vender partner to solve issues, ensuring timely resolution of incidents with minimal impact on business continuity.
Benefits
- general: Competitive benefits
- general: Collaborative culture
- general: Support for professional and personal growth and well-being
- general: Competitive and comprehensive Total Rewards Plans aligned with local industry standards
Tags & Categories