Zydus Lifesciences hiring Research Scientist – Pharmacokinetics
Research Scientist – Pharmacokinetics
R&d – Ptc Ahmedabad|ptc – Ahmedabad, Ahmedabad, Gujarat, India
Division; PTC – MORAIYA
Employee Type; P-P5-Probationer-R&D Staff
Experience range (Years) 0 – N.A.
Job Description;
- Bioequivalence study designing for different dosage forms and overseeing study execution as per applicable regulatory requirements.
- Review of the clinical study protocol
- BE result interpretation & correlation with in-vitro dissolution data.
- Monitoring of BE studies as per GCP, GLP, and applicable regulatory requirements.
- Drafting/reviewing regulatory deficiency responses and ensuring timely response submission.
- Review and finalization of the clinical study reports.
- Facilitate submission of DCGI BENOC application, drafting and coordinating the query response for approval.
- Support in drafting controlled correspondence/meeting documents for communication with regulatory agencies for their guidance.
- Coordination with CROs for timely and effective execution of clinical studies.
- Proficiency in Phoenix WinNonlin, MS Excel and PowerPoint
Research Scientist – Pharmacokinetics
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