About The Role

Research Scientist - Pharmacokinetics Sr. No. Job Description - Roles and Responsibilities 1 Preparation of study synopsis for BA/BE studies. Coordination with CRO for feasibility and budget. 2 Thorough understanding in different regulatory guidance and clinical pharmacokinetics 3 Provide technical input during protocol development and regulatory correspondence. 4 Coordination with cross functional teams and CROs for BA/BE studies and BENOC/TL application 5 Ensure execution of pilot and pivotal bioequivalence studies in compliance with study protocol. 6 Monitoring of Clinical studies in compliance with GCP, GLP and applicable regulatory requirements. Preparation of Monitoring reports. 7 PK data interpretation 8 Review of Study report 9 Post submission regulatory query response 10 Proficiency in Phoenix & MS Office will be an added advantage

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