Keerthika Gogula
Principal Medical Writer @ICON plc
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WORK HISTORY
Principal Medical Writer @ICON plc
Berlin, DE
As a Medical writing Program Lead, I serve as a subject matter expert for the program and liaise with the functional leadership to achieve overall program objectives.Authoring CHMP Scientific Advice, USFDA Briefing Documents, IND modules 1.20, 2.2 and 2.5, Responses to Health Authority Questions, Key Elements Form for EMA, PIP modifications and PIP responses to EMA/PDCO, Clinical Study protocols (including basket protocols) and protocol amendments, protocol plain language summaries, Clinical Study Protocol amendments and Briefing books for China, Global Investigator’s Brochures, and other regulatory clinical documents for Takeda Pharmaceuticals (Gastrointestinal and Inflammation Therapies; Rare diseases).
EDUCATION
Delhi Institute of Pharmaceutical Sciences and Research(DIPSAR) (College of Pharmacy) University of Delhi
Masters in Pharmacy
J.S.S.College of Pharmacy, Mysore
B.Pharmacy
National Academy of Legal Studies & Research (NALSAR) University Hyderabad
P G Diploma in Patent Law
Sanghamitra School
A.I.S.S.E
ABOUT KEERTHIKA GOGULA
I have sound knowledge of regulatory submissions for US FDA and EMA & have good…
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