Job Title: Senior Associate, Data Management
Location: India – Hyderabad (On Site)
Job ID: R-206635
Date Posted: April 22, 2025
Category: Regulatory
Company: Amgen
Job Summary
Amgen is seeking a Senior Associate, Data Management to play a crucial role in driving regulatory initiatives within Veeva RIM Vault. In this position, you will maintain data, support regulatory processes, and ensure compliance with evolving global regulations like IDMP, EU CTR, and other key standards. As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams, deliver training, and drive process improvements to align with regulatory requirements.
Key Responsibilities
Maintain regulatory data within the Veeva RIM Vault system
Archive clinical trial submissions, marketing applications, and health authority correspondence
Lead implementation of regulatory processes like Veeva Vault, XeVMPD, and IDMP
Provide support for data streamlining projects, report creation, and analysis
Develop and deliver training materials for global teams
Manage protocol amendment and investigator submission updates
Support the submission of 1572 forms to the FDA
Adhere to Amgen’s SOPs, policies, and guidelines
Assist the global data management team during peak workload periods
Required Skills and Experience
Familiarity with Global Clinical Trial Applications, marketing authorizations, and regulatory guidance
In-depth understanding of Veeva Vault RIM system
Strong analytical and problem-solving skills
Ability to manage time independently and prioritize tasks efficiently
Effective communicator with presentation skills
Ability to work well in global, matrixed teams
Fluent in English, both written and verbal
Preferred Skills
Advanced knowledge of Veeva Vault RIM
Experience working in global teams and matrix organizations
Ability to adapt to change and adopt new technologies
Education and Experience
Master’s degree and 1-2 years of related experience
Bachelor’s degree and 2-3 years of related experience
Associate’s degree and 3-5 years of related experience
High school diploma/GED and 5+ years of related experience
Why Join Amgen
Drive regulatory initiatives with cutting-edge technologies
Collaborate with global teams to shape the future of regulatory operations
Focus on continuous improvement and compliance across global markets
How to Apply
Visit: careers.amgen.com
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