Ganesh R. Manjeri
Principal Medical Writer @GSK
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WORK HISTORY
Principal Medical Writer @GSK
Bengaluru, IN
1) Work primarily in regulatory submissions to global health authorities by developing Module 2 documents of the CTD such as- Clinical summaries for Safety and Efficacy- Clinical Overviews2) Facilitating regulatory interactions with global health authorities by developing Briefing Documents, Information Requests and Response to Questions3) Submission Planning and Execution
EDUCATION
University of Leicester
M.Sc, Cancer Cell and Molecular Biology
Radboud University
Doctor of Philosophy (PhD), Medical Sciences
St. Xavier's College
B.Sc, Zoology and Biochemistry
ABOUT GANESH R. MANJERI
PhD in Mitochondrial Medicine from the labs of Prof. Jan Smeitink and Dr. Peter Willems at Radboud University Nijmegen, The Netherlands.Principal Medical Writer at GlaxoSmithKline, leading clinical regulatory submissions to global health authorities for IND/NDA/BLA/MAA.Experience and Expertise: Clinical Regulatory Writing - Submissions to Global Regulatory Authorities.Clinical Documents for Regulatory Submissions: Clinical Study Protocols, Investigators Brochure, Clinical Study Reports for Clinical (Interventional) and Epidemiological studies (Observational i.e. Database, Burden of Disease), Lay Summaries, Clinical summaries for safety and efficacy, Clinical Overviews and Briefing book.Other Clinical Document(s): Clinical Development Plans.Clinical Sciences Lead (during 2022) at GSK, involved in clinical development of a candidate vaccine asset, Phase 1/2 study.Medical Communication (Oncology)- Standard Responses, Slide-sets for Internal and External Medical knowledge sharing, Pivot charts to assess content usage on priority brands.
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