Associate Systems Analyst - docuBridge

Hyderabad, Telangana
Permanent
Full-time

1 month ago

Career Category Information SystemsJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Associate Systems Analyst - docuBridgeWhat you will doAssociate Systems Analyst - DocuBridge in this role will play a key role in implementation and lifecycle management of structured regulatory submission solutions, with a main focus on Lorenz DocuBridge. This role demands, hands-on experience with Lorenz DocuBridge, and the ability to assist in collaborating with multi-functional partner relationships across business, IT, and vendor teams. The candidate will collaborate with internal Regulatory Affairs stakeholders and vendor partners to ensure accurate interpretation of requirements. The role includes assisting in validation testing, user grievance resolution, and overall user experience optimization. Timely submission is critical, and the candidate must support the project to closure within set timelines and quality standards.

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 11guidelines.
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 youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with these qualifications.Basic Qualifications:

Bachelor’s degree and 2 to 6 years of relevant experience

Must-Have Skills:

Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
Experience in applying technology standard process methodologies such as Scaled Agile (SAFe) and ITIL.
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

Good-to-Have Skills:

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)

Professional Certifications:

SAFe® for Teams certification (preferred)

Soft Skills:

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

Shift Information:This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now and make a lasting impact with the Amgen team.careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation..

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