Zydus Lifesciences hiring Research Scientist – Pharmacokinetics

• Zydus Lifesciences hiring Research Scientist – Pharmacokinetics
• Research Scientist – Pharmacokinetics

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

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