Jubliant Generics – Urgent job openings Research Scientist – Medical Affiars | Apply Now

Jubliant Generics - Urgent job openings Research Scientist - Medical Affiars | Apply Now

Job Title: Research Scientist
Function: Medical & Scientific Affairs
Qualification: P.hD /M Pharma
Experience : 5-7years
Location : Noida
Job Description:

  • Literature review, collation of published pharmacokinetic (PK) data and development of bio strategy notes/document for pipeline projects
  • To oversee development, review and finalization of pilot and pivotal BE protocols and support regulatory team (DRA) for timely application of local regulatory permissions (BE NOCs/T-BE-licences)
  • Planning and execution of BE studies
  • Coordination with Plant and R&D teams for timely delivery of the investigational products (IPs)
  • Monitoring of pilot and pivotal BE studies sponsored by Jubilant Generics Limited
  • Ensuring timely receipt of BE reports, reviewing the same prior to submission to regulatory team (DRA)
  • Computation of pharmacokinetic and statistical analysis using WinNonlin software
  • Reviewing the BE data for planning of further studies. This includes analysis of PK data so as to make appropriate recommendations to the formulation development team
  • Identification of discriminatory/bio-relevant dissolution media, whenever possible based on the availability of pertinent data
  • Development of appropriate in vitro in vivo relationship/correlation (IVIVR/IVIVC) using a variety of methodologies whenever this is required and is considered feasible

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