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Amgen
Sr Associate IS Analyst - docuBridge
Sr Associate IS Analyst - docuBridge at Amgen, Hyderabad. Manage regulatory submission solutions using Lorenz DocuBridge. 5-9 yrs pharma IT experience, FDA/EUCTR compliance knowledge required. Competitive benefits, growth opportunities.
Direct Hire
Senior
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Job description
Posted on:
July 11, 2025
Join Amgen's mission to serve patients with serious illnesses by implementing and managing structured regulatory submission solutions, including Lorenz DocuBridge. Collaborate with internal teams and vendors to ensure accurate interpretation of requirements, delivery of compliant submissions, and successful deployment of the solution.
Requirements
- Master's degree / Bachelor's degree and 5 to 9 years of relevant experience
- Deep understanding of pharma industry regulations and compliance requirements for FDA and EUCTR
- 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
- Exceptional collaboration, communication, and flexibility in a rapidly changing and demanding environment
- Strong knowledge of information systems and network technologies
- Good-to-Have Skills: Familiarity with relational databases, proficiency in programming languages, outstanding written and verbal communication skills
Benefits
- Competitive benefits
- Comprehensive Total Rewards Plans
- Inclusive environment of diverse, ethical, committed and highly accomplished people
- Collaborative culture
- Opportunities for professional and personal growth and well-being
Requirements Summary
Master's degree / Bachelor's degree and 5-9 years of experience. Strong technical expertise and hands-on experience with Lorenz DocuBridge. Excellent collaboration, communication, and flexibility
