Regulatory Affairs Scientist

Focus: Paediatric Field

Description

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.

Qualifications

• 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).

Type
Research Fellow

Entry level and salary
To be evaluated based on the real experience of the candidate

Job location
Roma (Italy)

18/06/18, Martina Barcaroli