Medical Writing Associate I
Date: Jun 21, 2022
Location: Navi Mumbai, IN, 800048
Company: Teva Pharmaceuticals
Who are we?
Job Description
• Preparation/Review of Protocol and Informed consent form as per the regulatory requirement
• Literature search
• Preparation of REMS
• System improvements as required on day-to-day basis as per business requirements.
• Knowledge of Basic Aspects of pharmacology including Pharmacokinetics and Pharmacodynamics
• Knowledge of Basis concepts in Statistics
• Knowledge of various guidelines like ICH-GCP E6, ICMR, Schedule Y and Bioequivalence guidelines of applicable regulatory bodies.
• Knowledge of ICH E3 guidelines “STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS”.
• Good Knowledge on M2 eCTD Electronic Common Technical Document Specification
• Scientific Writing skills
• Good knowledge on word and excel
Qualifications
• 4 -6 years’ experience
• Postgraduate, M Pharm / MSc in life sciences background
Function
Sub Function
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