Experienced candidates can apply for Manager - Medical Writer @ Dr. Reddy's Laboratories Ltd.
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.
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