Career Category
Scientific
Job Description
Manager, Biomedical Data Stewardship (India)
What you will do

Amgen is expanding its global Biomedical Data Stewardship (BMDS) capabilities, with Amgen India (AIN) playing an increasingly critical role in integrated delivery and functional leadership. As Manager, Biomedical Data Stewardship, you will help advance Amgen’s Protocol standards and support MDR needs through India-based execution while partnering closely with global BMDS and cross-functional teams.

You will act in support of the Design & Innovation function within the Center for Design & Analysis. This position combines hands-on technical depth and cross-functional collaboration to ensure data standards are fit-for-purpose, inspection-ready, and aligned with Amgen’s global clinical development strategy.

Responsibilities:
- This role supports global Biomedical Data Stewardship objectives through India-based execution and cross-functional collaboration.




- Collaborate with global BMDS leadership and cross-functional partners to ensure alignment with enterprise standards strategy.
- Provide subject matter expertise in protocol standards, structured authoring, and library implementation to ensure consistent and compliant protocol development across therapeutic areas.
- Collaborate cross-functionally with Global Regulatory Writing (GRW), Clinical Development, Regulatory, TA SMEs, Dev IS, and other stakeholders to ensure alignment between governed standards and protocol authoring practices.
- Support and champion impact assessments, change control documentation, stakeholder communication, and implementation planning for library updates.
- Liaise with cross-functional teams to ensure consistent and timely implementation of approved libraries across studies and programs.
- Review protocols to ensure compliance with appropriate protocol libraries; provide feedback and guidance to study teams.
- Support development and maintenance of implementation guides, governance doc

📌 Manager, Biomedical Data Stewardship (Hyderabad)
🏢 AMGEN
📍 Hyderabad