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Medical Writing Associate II
Date: Jul 19, 2024
Location: Bangalore, India, 560052
Company: Teva Pharmaceuticals
Job Id: 57176
Who we are
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
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)
Teva's Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
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