Vacancy: In silico Regulatory Scientist

Voice Consulting Life Sciences (VCLS) is looking for a Regulatory Scientist specialised in in silico to join their French team in Boulogne, Paris

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:

  1. Search for, assimilate rapidly and then interpret correctly international regulatory environment.
  2. 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.
  3. Participate in gap analyses and identify potential gaps in in silico studies/trials, for nonclinical and clinical programs.
  4. Answer to client’s in silico and NC ad hoc questions and participate to teleconferences as necessary.
  5. Participate to in silico state-of-the-art consortium meetings; contribute to consortium document authoring.
  6. Create/maintain up-to-date in silico internal tools (e.g., in silico slide-deck and in silico knowledge management information).

Requirements

  • 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).

Full information can be found here


Date: 22/03/2022 | Tag: | News: 1306 of 1326
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