- 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.
- MedDRA and WHO-DD coding of clinical studies, review and lead when required.
- Preparation/Review of Clinical Study Reports, Appendices, OGD Tables, Module 2.7 ,CS-BE Tables and other supplementary documents as per the regulatory requirement
- eCTD processing of final clinical study reports.
- Carry out e-archival of documents
- System improvements as required on day-to-day basis as per business requirements.
- Maintenance of electronic Trial Master File (eTMF).
- Mentor team and as assigned, act as subject matter expert (SME)
- Project lead when assigned
Apply : https://careers.teva/job/Navi-Mumbai-Medical-Writing-Associate-I-400706/999937200/
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