Job Title:
Associate - Clinical Trial Submission Management
Job Location:
India - Hyderabad
Company:
Amgen
Job ID:
R-206611
Job Type:
Full-Time (On-Site)
Role Overview:
The Associate in Clinical Trial Submission Management ensures the technical compliance of Clinical Trial submissions and the smooth flow of information between functional areas, local offices, external partners, and regulatory authorities, with a focus on EU Clinical Trials Regulation (EU CTR).
Roles & Responsibilities:
Clinical Trial Application Management:
Responsible for ensuring the approval of Clinical Trial Applications (CTAs) in the EU throughout the study lifecycle.
Serve as a technical expert for the EMA Clinical Trial Information System (CTIS) and ensure compliance with EU CTR for all Clinical Trial submissions.
Collaboration & Coordination:
Support the EU Regulatory Lead in preparing Submission Content Plans and documentation for regulatory deliverables.
Ensure Quality Control (QC) of data and documents before upload into CTIS.
Coordinate Requests for Information (RFI) processes, from reviewing to document preparation and submission in CTIS.
Submission & Archiving:
Coordinate the accurate and timely input of data for Clinical Trial Notifications via CTIS and archive the data into the relevant internal system.
Process Development & Problem Solving:
Assist in developing and implementing processes to meet evolving CTIS needs.
Resolve any issues that may impact submission processes or timelines within CTIS.
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 from Amgen:
Support for Professional & Personal Growth:
Amgen supports your growth with competitive benefits, a collaborative culture, and a Total Rewards Plan aligned with industry standards.
Application Link:
Apply Now:
Amgen Career Portal
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