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Teva Medical Writing Associate II India, Karnataka, Bengaluru 67126777
21.07.2024
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How you’ll spend your day
- Candidate having background in Regulatory Affairs (RA) writing.
- Proficient in Module 2 preparation of documents
- Module 2 includes writing sections of - 2.4 nonclinical overview, 2.5 clinical overview, 2.6 Nonclinical Written and Tabulated Summary and 2.7 Clinical Written and Tabulated Summary as per specific market requests
- Knowledge in extensive literature search supporting basic elements based on SmPC of reference product reference product, safety and efficacy and bioequivalence study summary
- Knowledge on reliable databases like Embase, Clinical pharmacology, Cochrane Library, PubMed, ScienceDirect, Micromedex and similar
- Categorization of literature references according to sub-sections of module 4 and 5
- Good knowledge to interpret templates for writing sections as final submission documents on English
- Having exposure to Electronic data Capture tool like GRIDS etc to import expert reviews and supporting final submission
Your experience and qualifications
- Experience : 3-8 years in RA Writing
- Qualification: Master of Pharmacy (Pharmacology)
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