Dr. Reddy's is hiring Medical Writer Manager "A"

Manager - Medical Writer

1 - 4 YearsHyderabad / Secunderabad 

Job Description

Preparing and reviewing regulatory dossiers (Schedule Y, Medical rationales and Dossiers) for India, Russia and CIS and LATAM countries as per the country specific regulatory requirements.

Preparing and reviewing CTDs (Common technical documents Module 2, 4 &5), For US, EU/ India /Australia/Ukraine/ Kazakhstan/ Myanmar/Venezuela and Vietnam.

Preparing and reviewing of Summary of Product Characteristics (SPC), Package Insert (PI), and Package Information Leaflet (PIL), for India, ANZ, and Emerging Markets depending on recommendations from the regulatory authorities and on global safety updates.

Preparing the presentations and documentation required for interface with regulatory authorities.

Reviewing the PK Studies/BE study reports and provide critical assessment on the same.

Reviewing the dossier in total including clinical and nonclinical sections along with BE studies and PK studies.   

 Company Profile

Dr. Reddy's Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to  providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. For more information, log on to: www.drreddys.com

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