Job Description
Location
Bogotá, Colombia
Responsibilities
- Receive data from affiliates and consolidate reports for regional teams.
- Include updates for the global plan in the template based on information received from RA leaders.
- Follow up with QA, clinical, and TPM areas to request modules ensuring dossiers can be prepared by RA specialists.
- Keep the RA database 2024 plan updated according to approvals or submissions reported by affiliates.
- Ensure change controls activities are uploaded in the system and reminder notifications sent to owners to close the change control.
- Notify deviations to their respective due dates.
- Track indication updates in the risk assessment for labeling distribution.
- Verify inserts versions approved by manufacturing and receiving countries.
- Upload dossiers for submission and validate their visualization in DARIUS.
- Ensure correct fillin...