Provide platform and process support in the execution and management of Regulated Activities: ONIS (Observational and non interventional studies), External Research (IIS and ECRs) and Early Access Treatments (OOS and CUPs).
- Maintain the systems up to date following our internal processes and guidelines.
- Generate system reports.
- Understanding the process execution according to standard processes.
- Support the organisation of key alignment meetings with relevant stakeholders.
- Consolidating meeting minutes to share with stakeholders.
- Documents archive and administration.
- Bachelor's degree in science related careers (pharmacy, biology, chemistry, among others).
- Familiar with the regulated environment (GxP).
- Basic knowledge of digital platforms used for applications submission and management.
- English fluent in written, reading, speaking - work will be 100% in English.
- Solid project management skills.
- Strong organizational skills, service-oriented, and attention to detail.
- Ability to multi-task and function under high pressure environments.
- Proactive attitude and willingness to learn in a collaborative environment.
