USV is aleading healthcare company with the following areas of focus: Generics, Active Pharmaceutical Ingredients (APIs) and Biosimilars. 68% of our business is contributed by India Operations and the rest by export of APIs and Generics.
USV is a 48 year old healthcare company which began as a joint venture with USV&P Inc, a subsidiary of Revlon. Product range consists of Generics, Active Pharmaceutical Ingredients and Biotherapeutics that are manufactured in our modern cGMP compliant plants located in India.
Post: Medical Writer
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
Candidate Profile:
Experience in Medical Writing
Additional Information:
Location: Mumbai
Education: B.Pharm, M.Pharm
Industry Type: Pharmaceuticals
Functional Area: Writing/Editing
End Date: 25th August, 2015
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