I am Kishan, Medical Technical Writer with specialized expertise in regulatory compliance and clinical documentation within the pharmaceutical industry. My professional journey has been marked by extensive experience in managing and drafting FDA submissions, ensuring strict adherence to international standards like ICH/GCP and GMP.I am dedicated to advancing medical writing and regulatory strategies that significantly enhance drug development and marketing initiatives.
Abbvie
View- Website:
- abbvie.com
- Employees:
- 46234
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Sr Medical Technical WriterAbbvie May 2022 - PresentChicago, Illinois, United StatesDeveloped and drafted regulatory, clinical, and scientific documents for pharmaceutical projects, including risk analyses and study reports. Also, provided medical writing across various disciplines for regulatory submissions and quality initiatives, while ensuring document standardization and quality within the team.
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Medical Technical WriterJohnson & Johnson Nov 2020 - Apr 2022Managed QC and developed a wide range of medical and regulatory documentation, ensuring adherence to SOPs and regulatory standards. Collaborated across teams for document drafting, technical specifications, and training to uphold best practices in medical writing. -
Medical WriterBiogen Jan 2018 - Oct 2020Cambridge, Massachusetts, United StatesManaged regulatory document review and strategic collaborations for drug development submissions, ensuring compliance with FDA, ICH guidelines, and GCP. Coordinated with regulatory agencies, CRO/CMO, and managed eCTD submissions, document quality, and timelines for clinical and non-clinical regulatory requirements. -
Medical WriterBristol Myers Squibb May 2015 - Dec 2017New Jersey, United StatesContributed to QC processes, CAPA initiatives, and medical writing, coordinated FDA electronic submissions, and supported clinical trial management and business development within regulatory frameworks.
Kishan P Education Details
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Computer Science
Frequently Asked Questions about Kishan P
What company does Kishan P work for?
Kishan P works for Abbvie
What is Kishan P's role at the current company?
Kishan P's current role is Medical Writer.
What schools did Kishan P attend?
Kishan P attended The University Of Tennessee At Chattanooga.
Who are Kishan P's colleagues?
Kishan P's colleagues are Nuru Aliyu, Daniel Herbert, Daniel Dellert, Mira Elkour, Serena Piciccia, Divya B, Ilias Kalafatakis, Msc, Phd.
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