Roles & Responsibilities:
- Be assigned to one or more Amgen products under development to ensure Clinical Trial Application approvals in the EU throughout the whole 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.
- Be responsible for the Quality control (QC) of data and documents before CTIS upload.
- Be responsible for the cross-functional coordination of Requests for Information (RFI) process from initial reviewing and triaging, through to technical document preparation, submission in CTIS and archive in the relevant internal system.
- Be 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 process or timelines within CTIS.
what we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these 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
