CLINICAL RESEARCH ASSOCIATE @ Ipca Laboratories Limited,
For M.Pharma Candidates
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 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 visit at CRO to verify source
documents.
Monitor the progress of 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 proper execution of BE
studies.
Responsible for handling regulatory queries.
Responsible for overall conduct and management of BE
activities.
Co-ordinating for 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 as Bioequivalence Study
Year(s) in the same function
Year(s) in the same industry
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