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Our performance-oriented culture and dynamic business approach attract top talents in many areas, including R&D, marketing and sales, finance and administration. This helps us run a team full of young minds as well as industry veterans who work constantly towards improving the lives of millions.

Position: Clinical Research Associate – Bioequivalence Studies

Location: Mumbai, Maharashtra

Division Head Office Department MEDICAL AFFAIRS & CLINICAL RES
Designation CLINICAL RESEARCH ASSOCIATE Job title BIOEQUIVALENCE STUDIES
No. of Positions 1 Position Type Full Time

 

Job Responsibilities
  • Reviewing BE study protocols received from CRO and ensuring its completeness with respect to scientific and regulatory requirements.
  • Reviewing in vitro dissolution data received from R & D in line with the available guidance.
  • Reviewing the draft and final BE study report and ensuring its correctness as per applicable regulatory requirements.
  • Maintaining BE study-related documents for respective studies.
  • Perform monitoring visits at CRO to verify source documents.
  • Monitor the progress of the study and ensure the timelines as per the agreed task order.
  • Finalizing study-specific task order with the selected CROs.
  • Co-ordinate with the CROs for the proper execution of BE studies.
  • Responsible for handling regulatory queries.
  • Responsible for overall conduct and management of BE activities.
  • Co-ordinating for an import license and BE NOC with the regulatory team.

 

Job Specifications
Age Group 25 to 30 Year(s)
Educational Qualifications M PHARM
Experience (years) 1 Year(s)
Experience(Job-Related) Less than 5 Years
1 Years in Bioequivalence Study

 

Contact Details: hrd.mumbai@ipca.com, hrdtech.mumbai@ipca.com

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