Medical Writers required "A"

Medical Writer

USV Pvt Limited

3 - 7 yrs

Mumbai

Job Description

Experienced in writing Module 2 (Clinical part) and Module 5.
Preparation of Clinical overviews and non clinical overviews, scientific justifications, Biowaiver justification and Medical rationales.
Knowledge of clinical guidelines of ICH, EMA and FDA
Experience in biosimilar or biologics
Writing of clinical study summaries and reports
Awareness of CTD / eCTD requirements
Writing pharmacovigilance plan and risk management plan


Please share your CVs to hrd@usv.in with Position title and code as AM07 in subject.

Company Profile:

USV Pvt Limited

We are a leading health care company with the following areas of focus: Branded Generics, Active Pharmaceutical Ingredients (APIs & Formulation) and Bio-similars. Sixty-eight percent of our business is contributed by the India operations and the rest by export of APIs & Formulations and Branded generics.  

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