Clinical Trial Fresher Jobs | Amgen – Associate Clinical Trial Submission Management

Clinical Trial Fresher Jobs | Amgen – Associate – Clinical Trial Submission Management

Career in Clinical Trials with Amgen!

Amgen, a global biotechnology leader, is hiring an Associate – Clinical Trial Submission Management in Hyderabad, India. This could be your perfect opportunity if you have a Bachelor’s degree or Diploma and an interest in clinical research.

Why Join Amgen?

At Amgen, we are committed to advancing medicine and making a difference in patients’ lives. As an Associate in Clinical Trial Submission Management, you will play a crucial role in ensuring smooth regulatory submissions and compliance with clinical trial regulations.

Job Details

Position: Associate – Clinical Trial Submission Management

Location: Hyderabad, India
Job ID: R-206610
Category: Safety
Work Type: On-site
Experience Required: 0-3 years (Bachelor’s degree) or 4-7 years (Diploma holders)

Roles & Responsibilities

As an Associate – Clinical Trial Submission Management, you will:

• Ensure technical compliance of Clinical Trial submissions by coordinating information flow between stakeholders.
• Support Clinical Trial Application approvals in the European Union (EU) throughout the entire study lifecycle.
• Act as a technical expert in the EMA Clinical Trial Information System (CTIS) and ensure compliance with EU Clinical Trials Regulation (EU CTR).
• Prepare Submission Content Plans and regulatory deliverables in coordination with the EU Regulatory Lead.
• Conduct Quality Control (QC) checks on data and documents before submission in CTIS.
• Manage the Request for Information (RFI) process, from document preparation to final submission.
• Coordinate Clinical Trial Notifications through CTIS and maintain internal documentation records.
• Assist in process improvements to enhance CTIS submissions and compliance workflows.
• Identify and resolve any regulatory submission challenges to ensure timely approvals.

Qualifications & Skills

Basic Qualifications:

Bachelor’s degree with 0-3 years of experience OR
Diploma with 4-7 years of experience

How to Apply?

Ready to launch your career in Clinical Trial Submission Management? Apply now and become part of a company that is transforming healthcare!

🔗 Apply Here: Amgen Careers

Tagged as: Good Clinical Practice (GCP)