MAC Reference Librarian
Location: Hyderabad, India
Job ID: R-218806
Posted On: July 1, 2025
Employment Type: Full-Time | On-Site
About Amgen:
Amgen is a global biotechnology leader dedicated to advancing innovative therapies for serious illnesses. For over four decades, Amgen has blended cutting-edge science with pioneering technology to deliver impactful medicines that improve lives. With a focus on patient-centered innovation, Amgen continues to redefine the future of healthcare.
About the Role:
As a MAC Reference Librarian, you will manage and maintain Amgen’s digital Reference Library and Match Text Library within the Veeva PromoMats system, ensuring compliance with regulatory standards and internal SOPs. You will play a key role in supporting cross-functional Material Approval and Compliance (MAC) teams and global promotional initiatives. This role demands a high level of quality control, organization, and collaboration across US MAC teams, marketing agencies, and regulatory partners.
Key Responsibilities:
Manage Reference and Match Text Libraries for multiple US MAC teams, including annual reviews and updates.
Add, modify, and perform Quality Checks (QC) on Match Text and reference records in Veeva PromoMats, ensuring alignment with Amgen’s Reference & Annotation (R&A) standards.
Organize and maintain Amgen Label Reference documents in Veeva and support global regulatory initiatives.
Serve as a subject matter expert on MAC reference requirements and provide ongoing training and office hours to stakeholders.
Maintain the MAC Reference Library email inbox, manage project workflows, and ensure timely resolution of issues.
Partner with cross-functional teams including Material Compliance Managers (MCMs), MCA, SciComm, and agencies to troubleshoot QC concerns and enhance reference linking.
Contribute to global MAC-related projects and assist in process improvement initiatives.
Author and maintain SOPs, work instructions, and training materials related to the Reference Library.
Required Knowledge and Skills:
Strong knowledge of Veeva PromoMats and digital library systems.
Excellent oral and written communication skills with a proactive, collaborative mindset.
Demonstrated project management skills, including the ability to manage high-volume digital assets in a regulated environment.
Strong critical thinking and problem-solving abilities.
Ability to navigate ambiguity and apply both strategic and tactical thinking.
Attention to detail and experience in reference management and QC protocols.
Proven ability to operate in matrixed, cross-functional teams.
Preferred Knowledge and Skills:
Understanding of the pharmaceutical commercialization process, including regulatory promotion guidelines.
Experience with Adobe tools (e.g., Photoshop, Illustrator, Acrobat Pro).
Familiarity with medical reference support for high-volume promotional content.
Strong background in managing digital reference libraries in a global or regulatory setting.
Basic Education and Experience:
Bachelor’s degree and 6 years of relevant experience
OR
Associate’s degree and 10 years of relevant experience
Preferred Education and Experience:
Bachelor’s degree and 6+ years in Global Regulatory Affairs or related field
Working Hours:
This position requires flexible AIN working hours, with occasional overnight availability to support US product launches and promotional updates.
Estimated Salary: ₹11–14 LPA (based on seniority and experience level)
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