Job Title: Associate GRAAS Operations
Location: India - Hyderabad
Job ID: R-204033
Work Location Type: On Site
Date Posted: Jan. 03, 2025
Category: Regulatory
What You Will Do:
Let’s do this. Let’s change the world. In this vital role, you will help ensure technical compliance of our Clinical Trial submissions via the smooth, compliant flow of information between all functional areas, local offices, external partners, and regulatory authorities.
Roles & Responsibilities:
Be assigned to one or more Amgen products under development to ensure Clinical Trial Application approvals in the EU throughout the study lifecycle.
As technical experts in the EMA Clinical Trial Information System (CTIS), ensure compliance with the EU Clinical Trials Regulation (EU CTR) for every Clinical Trial submission dossier through close cross-functional collaboration.
Support the EU Regulatory Lead to prepare Submission Content Plans and documentation for regulatory deliverables.
Perform Quality Control (QC) of data and documents before CTIS upload.
Coordinate cross-functional Requests for Information (RFI) processes from initial review and triaging, through to technical document preparation, submission in CTIS, and archival in the relevant internal system.
Act as the critical technical coordinator for Clinical Trial Notifications through CTIS, ensuring accurate and timely input of data and archive into the relevant internal system.
Assist with the definition, development, and implementation of processes to meet evolving CTIS needs.
Raise, advise, and resolve any issues that may impact submission processes or timelines within CTIS.
What We Expect of You:
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a collaborative, detail-oriented, and proactive individual with the following qualifications:
Basic Qualifications:
Bachelor’s degree and 0 to 3 years of directly related experience OR
Diploma and 4 to 7 years of directly related experience
Preferred Qualifications:
Practical experience with Veeva Vault
Familiarity with global regulatory processes and standards
Ability to quickly learn new software, regulations, and processes
Proactive, innovative problem solver and well-organized teammate
What You Can Expect of Us:
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
How to Apply:
Interested candidates can apply through our official website: www.amgen.com.
Let me know if we need to fine-tune anything further!
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