Kishore
Senior Medical Writer @Novo Nordisk
Signup · Get unlimited contacts
WORK HISTORY
Senior Medical Writer @Novo Nordisk
Bangalore Urban, IN
Performed various key tasks such as planning and preparing a wide range of regulatory documents such as paediatric investigation/ study plans, clinical trial reports, non-interventional study reports, investigator brochures, lay summaries, eCTD submission documents, Q&A response documents, and meeting packages. Managed stakeholders from various domains and have written multiple documents in different therapeutic areas, including diabetes, obesity, haemophilia, postpartum haemorrhage, Factor deficiency, Noonan syndrome, and Prader-Willi syndrome. Prepared and submitted abstracts and posters by collaborating with internal and external authors.\\\\n\\\\nKey highlights of my experience include:\\\\n• Served as a change agent for clinical study report template and trained new joiners from two medical writing teams.\\\\n• Served as a superuser for Endnote and have resolved a number of queries related to it.\\\\n• Generated slide decks for scientific advice meetings as well as internal and external results meetings for various clinical trials.\\\\n• Innovated an IT tool for automating blocking calendars for reviews and formulating meetings.\\\\n• Provided guidance for ordering literature full articles required for regulatory submission.\\\\n• Provided guidance for extracting list of clinical trials to be updated in a drug IB on an annual basis as well as delivered user-friendly guidance regarding utilisation of a macro assisted authoring tool to aid colleagues working on Word documentation.\\\\n• Have been an active contributor in team meetings and reviews and, solved problems with respect to authoring complex documents and dealing with tough stakeholders.\\\\n• Performed exceptionally well and secured promotion to Senior Medical Writer position.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
EDUCATION
Andhra University
Masters in Pharmacy, Pharmaceutical technology, First class
Cliniminds
Certificate program in Aggregate reporting, pharmacovigilance, 87 %
Jawaharlal Nehru Technological University, Kakinada
Bachelor of Pharmacy (BPharm), Pharmacy, First class with Distinction
ABOUT KISHORE
Hi, I am Kishore and thank you for visiting my profile! I am a conscientious professional with experience in preparing: • Clinical trial reports • Clinical trial protocols • Paediatric investigation/ study plans (PIP/PSP) • Non-interventional reports • eCTD clinical summaries (Modules 2.5, 2.7.1, 2.7.2 and 2.7.4) • Investigator brochures • Lay summaries • Responses to Questions (RTQs or Q & As) from various regulatory authorities • Meeting packages/ briefing documents (for meetings with FDA, EMA, Swissmedic and NMPA [China]) • Scientific abstracts and posters I have earned the credential of “Medical writer certified (MWC)” after successfully completing the rigorous process of application and examination process developed and administered by the Medical Writing Certification Commission (MWCC) of the American Medical Writers Association (AMWA). I am fortunate to manage stakeholders from various domains and author documents in different therapeutic areas like diabetes, obesity, haemophilia, postpartum haemorrhage, Factor deficiency, Noonan syndrome and Prader-Willi syndrome. I have a comprehensive experience in pharmacovigilance (ICSR case processing and literature review) with a clear picture of drug safety in the overall drug development. I am an intuitive and perceptive individual with an \"always open\" attitude towards learning new skills and would like to challenge the status quo when it lacks logic. I believe in lifelong learning, whether experiential or theoretical.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.