Jubilant Pharma Limited Hiring Research
Scientist-Medical Affairs Apply Now
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
Qualification: P.hD /M Pharma
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