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Teva Medical Writing Associate II 
India, Karnataka, Bengaluru 
67126777

21.07.2024
How you’ll spend your day
  1. Candidate having background in Regulatory Affairs (RA) writing.
  2. Proficient in Module 2 preparation of documents
  3. 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
  4. Knowledge in extensive literature search supporting basic elements based on SmPC of reference product reference product, safety and efficacy and bioequivalence study summary
  5. Knowledge on reliable databases like Embase, Clinical pharmacology, Cochrane Library, PubMed, ScienceDirect, Micromedex and similar
  6. Categorization of literature references according to sub-sections of module 4 and 5
  7. Good knowledge to interpret templates for writing sections as final submission documents on English
  8. 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)