Job Description

1. Literature search, preparation of Clinical study protocols according to Guidelines and Regulatory Requirements by using Product Monographs/Prescribing Information/Summary of Product Characteristics etc., as applicable.
2. MedDRA and WHO-DD coding of clinical studies, review and lead when required.
3. Preparation/Review of Clinical Study Reports, Appendices, OGD Tables, Module 2.7 ,CS-BE Tables and other supplementary documents as per the regulatory requirement
4. eCTD processing of final clinical study reports.
5. Carry out e-archival of documents
6. System improvements as required on day-to-day basis as per business requirements.
7. Maintenance of electronic Trial Master File (eTMF).
8. Mentor team and as assigned, act as subject matter expert (SME)
9. Project lead when assigned

Qualifications

M.Pharm

Apply : https://careers.teva/job/Navi-Mumbai-Medical-Writing-Associate-I-400706/999937200/