Tejas D. Kanhed Jain
Business Process Lead @Tata Consultancy Services
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WORK HISTORY
Business Process Lead @Tata Consultancy Services
Mumbai, IN
Experience in preparation of clinical/safety documents necessaryfor international regulatory submissions to the US, European andother regulatory agencies (Protocol,ICF,Narratives and IB). Write, edit, and manage the production of high quality clinical andnonclinical documentation including support of marketing applicationssuch as IND, NDA, BLA, MAA and other equivalent applications. Lead the authoring/editing of clinical documents with minimalsupervision (Clinical Overviews,IB, Clinical Study Protocols, Clinical Study Reports). Manage medical writing projects independently, including clientcommunications, query resolutions and timeline adherence. Provide training and guidance to the team members as and when required. Proficiency of Ovid tool, PubMed, M-library, and Cochrane databases Ensure adherence to established processes, timelines, regulatoryguidelines and applicable standards, styles (Harvard and Vancouver),guidelines. Perform independent quality review of the clinical/safety documentswithin established timelines with adherence to applicable guidelines,templates, and processes. Keep abreast of project status, clinical operating plans and ongoing/newstudies as well as scientific literature within assigned project. Performs on-line clinical literature searches, as applicable Multitask with proven project management capabilities includingmanaging dynamic timelines, interacting, and negotiating with others,collaboration, and excellent follow-up. Detail-oriented to understand the “big picture” and overall strategy ofprojects/programs.
EDUCATION
Shri Bhagwan College of Pharmacy N 6 Cidco
Bachelor of Pharmacy, Pharmacy
R C Patel Institute of Pharmaceutical Education and Research Shirpur
M Pharmacy, Pharmacology and Toxicology
ABOUT TEJAS D. KANHED JAIN
Experienced Pharmacologist in Regulatory Medical Writing andRegulatory affairs with solid background and experience in managingclinical studies and collaborating to clinical research. Committed todelivering commercial awareness and collaborating with team to meetobjectives. Looking forward to becoming an efficient professional andproving my worth as an asset in a learning and competitive environment.Also, to take up new challenges with huge responsibility and be open tocontinuous improvement in the organization.
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