Job Title: Senior Associate, Data Management
Location: India – Hyderabad (On Site)
Job ID: R-206634
Date Posted: April 7, 2025
Category: Regulatory
Company: Amgen
Job Summary
Amgen is seeking a Senior Associate in Data Management to join the team in Hyderabad. In this role, you will leverage your expertise in Veeva RIM Vault to drive business operations, ensuring regulatory compliance with emerging global standards like IDMP and EU CTR. You will support the implementation of new processes, ensure efficient and high-quality regulatory data management, and contribute to training and the development of data standards. Your role will be critical in maintaining regulatory compliance across global markets while streamlining data management processes.
Key Responsibilities
Maintain and manage data within Regulatory Information Management (RIM) systems like Veeva Vault
Create and archive clinical trial and marketing application submissions and Health Authority correspondence
Lead and collaborate on cross-functional initiatives to implement regulatory processes, ensuring compliance with global standards
Support the implementation of regulatory initiatives like XeVMPD, IDMP, and others
Develop and deliver training materials and presentations for global teams
Manage protocol amendment submissions and 1572 forms for FDA submission
Support global data management efforts related to US CPP and EU CMP during peak workload periods
Adhere to Amgen’s processes, policies, and guidelines
Required Skills and Experience
In-depth understanding of Veeva Vault system
Strong familiarity with Global Clinical Trial Applications, Marketing Authorizations, and Regulatory Guidance
Good written and verbal communication skills in English
Critical thinking and problem-solving skills
Independent time management and prioritization skills
Ability to work in demanding situations with tact, diplomacy, and respect
Experience in supporting projects and improvement initiatives
Preferred Knowledge and Skills
Advanced knowledge of Veeva Vault RIM
Experience working in global teams and matrix organizations
Familiarity with CTIS system and global regulatory landscape
Education and Experience
Master’s degree with 1-2 years of directly related experience
Bachelor’s degree with 2-3 years of related experience
Associate’s degree with 3-5 years of directly related experience
High school diploma/GED with 5+ years of related experience
Why Join Amgen?
Global impact: Drive regulatory compliance in the fast-evolving biotech landscape
Collaborative culture: Be part of a dynamic team with a shared commitment to improving patient outcomes
Career development: Work in an environment that fosters continuous learning and growth
How to Apply
Visit: careers.amgen.com
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