Job ID: R-204033
Location: Hyderabad, India
Work Location Type: On-Site
Date Posted: Jan 03, 2025
Category: Safety
About the Role
In this essential role, you will contribute to the technical compliance of Clinical Trial submissions by ensuring the smooth flow of information between cross-functional teams, local offices, external partners, and regulatory authorities. You will focus on Clinical Trial Application (CTA) approvals in the EU, ensuring adherence to regulations and seamless interaction with the Clinical Trial Information System (CTIS).
Key Responsibilities
- Clinical Trial Application Compliance: Manage CTA approvals throughout the entire study lifecycle in the EU.
- Cross-Functional Collaboration: Collaborate closely with EU Regulatory Leads, ensuring smooth submission processes.
- Document Quality Control: Review and ensure quality control of data and documents prior to CTIS upload.
- Information Coordination: Handle Requests for Information (RFI) processes, from review to technical document preparation and submission.
- Technical Coordination: Oversee Clinical Trial Notifications, ensuring accurate and timely data input into CTIS and internal systems.
- Process Improvement: Assist in defining and implementing processes to meet evolving CTIS needs and resolve submission issues.
Qualifications
Basic Qualifications
- Bachelor’s degree with 0 to 3 years of related experience OR
- Diploma with 4 to 7 years of related experience
Preferred Qualifications
- Experience with Veeva Vault
- Familiarity with global regulatory processes and standards
- Strong ability to learn new software, regulations, and processes quickly
- Proactive, organized, and innovative problem solver