Alwin Kalambe
Medical Writer @Torrent Pharmaceuticals Ltd
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WORK HISTORY
Medical Writer @Torrent Pharmaceuticals Ltd
Gandhinagar, IN
Authored and reviewed clinical study documents, including Clinical Study Protocols, Amendments, Clinical Study Reports (CSRS) and Informed consent Forms, ensuring compliance with regulatory standards such as FDA, EMEA, ANVISA, and CDSCO. Collaborated with cross-functional teams to develop and implement Standard Operating Procedures (SOPs), which improved document quality and reduced revision time. Additionally, I pioneered new processes that increased productivity by reducing time spent on reviewing medical documentation.Conducted comprehensive (iterature reviews and ensuring alignment with regulatory guidelines, supporting successful submissions to global health authorities. Managed various study documents and assignments, delivering them on time and with high quality.
EDUCATION
EKLAVYA SCHOOL OF SCHOLARS, SAWARGAON
Class 10
NIPER Guwahati
MS(Pharm), Pharmacology and Toxicology
GURU NANAK COLLEGE OF PHARMACY ,NAGPUR
Bachelor of Pharmacy - BPharm, Pharmacy
NADEKAR JUNIOR COLLEGE OF SCIENCE
Class11-12, Science
ABOUT ALWIN KALAMBE
Just in search of those opportunities (as a ray of light) in the darkness to whom I can assure I can and I will accomplish.
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