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, governanc

📌 Manager - Standards Medical Writer (Biomedical Data Stewardship) (Hyderabad)
🏢 AMGEN
📍 Hyderabad