Regulatory Affairs Scientist
Focus: Paediatric Field
The Regulatory Scientist will have the responsibility in the scientific management and coordinating/administrative activities related to the paediatric studies, clinical trials and research projects carried out by INCIPIT.
In particular she/he will be responsible for:
- Support in scientific consultancy activities (Protocol writing, Paediatric Investigational Plan and Scientific Advice procedures, etc..).
- Clinical trial design, review/medical writing of clinical study documents.
- Contacts with National Competent Authorities (AIFA, EMA) and Ethic Commitees (es: preparation and follow-up of submission packages for clinical trials).
- Partecipating in evaluation of feasibility studies and sites selection.
- Budget and Agreement (related to clinical trials) negotiation.
- Research Project management and scientific activities (H2020, IMI2, etc..).
- Activating and maintaining contacts with Sponsors, INCIPIT clinical Sites, thematic networks, Scientific Societies.
- University degree in scientific fields (Pharmacy, Chemistry and pharmaceutical technology, Biology, Pharmaceutical Biotechnology, Biostatiscian).
- Good Knowledge of Good Clinical Practices, ICH guidelines, ethics, EU and country legislation related to clinical trials.
- Good knowledge of concepts and understanding of clinical research and drug development process (preferable knowledge in paediatric drug development).
- Ability to handle and prioritise multiple therapeutic areas and projects simultaneously.
- Ability to work effectively in a team/matrix environment.
- Advanced computer skills.
- Experience of at least 2 years in Regulatory Affairs field.
- Proficiency in English (spoken and written).
Entry level and salary
To be evaluated based on the real experience of the candidate