Job Description
Medical Writer
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.
