As Regulatory Scientist NC/C, you are a member of the Regulatory Strategy Department in the Nonclinical (NC) and Clinical (C) team (Reg NC/C). You will be involved mainly in tasks related to in silico medicine activities.
Role overview / In silico medicine tasks:
Your main tasks in in silico activities, under the guidance of more senior NC team members, will consist mainly (but not exclusively) to:
- Search for, assimilate rapidly and then interpret correctly international regulatory environment.
- Review and/or draft the in silico sections of documents or briefing packages to be submitted to competent authorities e.g., scientific advice/ pre-IND, CTA/IND, technical dossier and MAA/BLA/NDA.
- Participate in gap analyses and identify potential gaps in in silico studies/trials, for nonclinical and clinical programs.
- Answer to client’s in silico and NC ad hoc questions and participate to teleconferences as necessary.
- Participate to in silico state-of-the-art consortium meetings; contribute to consortium document authoring.
- Create/maintain up-to-date in silico internal tools (e.g., in silico slide-deck and in silico knowledge management information).
- Bachelor of Science degree or higher.
- Understanding of in silico medicine, nonclinical and clinical environment.
- Knowledge of in silico technologies (i.e., computational modeling and simulation, artificial intelligence, verification/validation/uncertainty quantification (VVUQ)) as demonstrated through a combination of work experience and/or academic background.
- Preferentially 2-3 years of professional in silico technologies (e.g., computational modeling and simulation, artificial intelligence, verification/validation/uncertainty quantification (VVUQ)) in the life sciences industry.
- Experience in a consulting environment is a plus.
- Good knowledge of the English language (written & spoken).
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