Posted By - IPCA Laboratories Ltd.. Keywords - Ability to manage competing priorities effectively. 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 draft and final BE study report and ensuring its correctness as per applicable regulatory requirements. Maintaining BE study related documents for respectiv
Clinical Research Associate - IPCA Laboratories Ltd
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 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.
Co-ordinate with different vendors like courier service, internal standard supplier etc
IP management / Accountability and dispatch of RLD & Test products to CROs.
Salary: INR 1,75,000 - 2,00,000 P.A
Industry: Pharma, Biotechnology, Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role: Clinical Research Associate/ Scientist
Key skills: Ability to manage competing priorities effectively
Desired Candidate Profile
Education: (UG - B.Pharma - Pharmacy) AND (PG - Any PG Course - Any Specialization, Post Graduation Not Required, M.Pharma - Pharmacy) AND ( Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required)
Please refer to the Job description above
Company Profile
IPCA Laboratories Ltd.
A fully integrated pharmaceutical company engaged in the manufacturing, marketing and distribution of API, pharmaceutical formulations and medicinal product across the globe.