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Tuesday, January 30, 2018

Medical Writing | Bangalore

Hiring for Medical Writing for BA_BE studies,Bangalore
Experience required for the Job: 2 - 7 years
Job Location: Bengaluru/Bangalore

Job Summary:
Responsible for execution of the study and system related activities as per the established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) best practices and regulatory requirements.
Job Responsibilities:
1. Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centers Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
2. Preparation of integrated clinical study report for the bioequivalence studies.
3. Collection, reviewing and summarizing (such as data entry onto the data base / clinical report templates) of clinical data and preparation of the clinical report as per e-CTD requirement.
4. CRF scanning, OCR and book markings as per e-CTD requirement.
5. Preparation of FDA DBE, CSBE tables and as per other regulatory requirements as applicable.
6. Performs and ensures clinic staff activities for compliance with protocol and SOPs.
7. Performs dosing related activities (such as dosing, dosing supervision, Test Article verification and mouth check).
8. Preparation and/or review of report tables for the allotted studies.
9. Performs the review of the study data for completion, correctness and accuracy.
10. Executes other duties as per the study specific protocol requirements and as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
11. Coordinates / communicates internal and / or with cross functional departments for study relevant activities.
12. Assists in the creation, development and revision of the Bioequivalence Centers Clinical Operations Department Standard Operating Procedures. 

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