Senior Research AssociateJobs Opening in Cadila Pharmaceuticals Ltd at Dholka
FEATURED JOBSenior Research Associate
Cadila Pharmaceuticals Ltd
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Posted: 07 Mar 26
Job Description
Major purpose of the Job :
-As a primary role Medical writing activities for BE and CT studies includes Preparation of Protocol, ICF, CRF and Clinical study report and as a secondary role pharmacy related activities of BE and CT studies.
-Submission of BE study documents to Regulatory department for BE NOC/ T license and IEC for its approval.
Responsibilities:
Medical Writer:
-Preparation of Protocol and its Amendments for BE studies.
-Preparation of ICF and CRFs for BE studies.
-Preparation of Phase I, II & III Synopsis, Protocol, Protocol Amendments, ICF and CRFs for CT studies.
-Preparation and Compilation of CSR for BE studies and eCTD of study report as per specific guidelines.
-Designing of Pharmacokinetic time points/feasibility for BE studies.
-Implementation of revisions on guidelines for medical writing and Preparation of SOP.
IEC submission activities.
-Submission of Protocol and other documents to regulatory department for DCGI NOC/ T license.
-Handling of regulatory agency deficiencies.
Pharmacist:
- Management of BE and CT pharmacy.
- Handling of IP including receipt, storage, dispensing, & retention of Investigational Product.
- Preparation of labels related to IP handling.
- Temperature data monitoring.
- Archiving of all pharmacy temperature data & logbooks.
-Any other additional activities assigned by Head of the department.
Job Particulars
Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2853802
Job Category Sales and Marketing
Locality Address
State Gujarat
Country India
About Company
Cadila Pharmaceuticals Ltd
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