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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, Maharastra
Job Description:
- 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.
Qualification: M.Pharma
Experience: 1-5 Years of Relevant Experience
Salary: Negotiable
Age Limit: 25-30 Years
Contact Details:
hrd.mumbai@ipca.com / hrdtech.mumbai@ipca.com
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