Sr Associate IS Analyst - docuBridge

Biopharma Careers; Hyderabad; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Amgen, a global biotechnology leader, is seeking a Sr Associate IS Analyst – DocuBridge to drive implementation and lifecycle management of structured regulatory submission solutions. The role focuses on Lorenz DocuBridge with collaboration across Regulatory Affairs, IT Security, Quality Assurance, and vendor teams.

You will help ensure timely, compliant submissions, assist in validation testing, and support end‑to‑end project execution from assessment to post‑production support, while aligning

Qualifications

• Master's or Bachelor's degree with 5–9 years of relevant experience.
• Deep knowledge of pharma industry regulations (FDA, EUCTR).
• Experience with DocuBridge and regulatory submission systems.
• Ability to manage multi-functional partner relationships and projects.
• Familiarity with SAFe and ITIL methodologies.

Responsibilities

• Lead implementation and lifecycle management of Lorenz DocuBridge for regulatory submissions.
• Collaborate with Regulatory Affairs, Quality Assurance, IT Security, and vendors.
• Define project plans, timelines, and resource allocation.
• Oversee validation plans and IQ/OQ/PQ protocols per 21 CFR Part 11.
• Ensure submission readiness and audit readiness.
• Provide user training and drive continuous system improvements.

Job description

Career Category

Information Systems

Job Description

Join Amgen’s Mission of Serving Patients

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.

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.

What you will do

Sr Associate IS 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 strong technical expertise, hands‑on experience with Lorenz DocuBridge, and the ability to assist in managing multi‑functional partner relationships across business, IT, and vendor teams. The candidate will collaborate with internal Regulatory Affairs team members and vendor partners to ensure accurate interpretation of requirements, delivery of compliant submissions, and successful deployment of the solution. 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 and system ownership 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 overseeing the development of 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.
• Oversee 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.
• Lead continuous improvement initiatives to enhance system usability, performance, and regulatory compliance alignment.
• Track KPIs and provide regular status updates to leadership on system performance, user adoption, and project‑level challenges and risks.
• Contribute to technology roadmap planning by finding opportunities for tool upgrades, integration with newer modules (e.g., Lorenz eValidator), and regulatory intelligence platforms.
• Act as the SME for structured submissions and represent the function during audits, inspections, and regulatory reviews.
• Demonstrate adaptability to agile methodology, ensuring flexibility and responsiveness to changing project requirements.
• Manage and lead teams effectively, fostering collaboration and productivity.
• Use Jira and ServiceNow for project tracking, issue resolution, and service management.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with these qualifications.

Basic Qualifications

• Master's degree / Bachelor's degree and 5 to 9 years of relevant experience

Must‑Have Skills

• Demonstrate a deep understanding of pharma industry regulations and compliance requirements for, including FDA and EUCTR.
• Have good knowledge of submission publishing systems like Lorenz’s docuBridge application and Regulatory Veeva RIM.
• Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent.
• 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.

Good‑to‑Have Skills

• Familiarity with relational databases (such as MySQL, SQL server, PostgreSQL etc.)
• Proficiency in programming languages such as Python, JavaScript or other programming languages
• Outstanding written and verbal communication skills, and ability to translate technical concepts for non‑technical audiences.
• Experience with ETL Tools (Informatica, Databricks).
• Experience with API integrations such as MuleSoft.