Talk to sales Try for Free
Ashish Amarsheda

Ashish Amarsheda

Clinical Research Associate

Followers of Ashish Amarsheda1000 followers
location of Ashish AmarshedaGujarat, India

Connect with Ashish Amarsheda to Send Message

Connect

Connect with Ashish Amarsheda to Send Message

Connect

  • Timeline

  • About me

    Assistant General Manager - Principal Medical Writer at Cadila Pharmaceuticals Limited

  • Education

    • A. R. COLLEGE OF PHARMACY & G.H.P. INSTITUTE OF PHARMACY(Diploma), V.V.NAGAR 401

      -
      Bachelor of Pharmacy (B.Pharm.)

      Activities and Societies: As a Delegate in Multiple seminar and workshops on clinical research.

    • M. B Patel Gyanjyot High School, Ahmedabad

      -

    • K.B. Institute of Pharmaceutical Education and Research

      2011 - 2013
      M.Pharm Clinical Pharmacy

      Activities and Societies: drug information center, clinical trial protocols, ward rounds

  • Experience

    • Ethicare clinical trial services

      Jul 2013 - Jan 2015
      Clinical Research Associate

    • Lincoln Pharmaceuticals Ltd,

      Jan 2015 - Jun 2016
      Clinical Research & International Regulatory affairs

      Preparation of ANDA dossier, Review of Clinical Trial & BA/BE study Protocol, ICF etc with Final report submission to DCG(I).Complete DMF, PDR, AMV, Stability etc.Regulatory Dossier preparation and submission for International submission.

    • Cadila Pharmaceuticals Limited

      Jun 2016 - now

      Prepare and review of all study documents like Protocol, Case Report Form (CRF), Informed Consent Form (ICF), Investigator Brochure (IB), Therapeutic Justification, etc.Clinical Study Report preparation as per ICH E3.Co-ordinating with F&D and QA department for precise documentation Prepare Therapeutic Rationale, Motivational Letter, etc. for IRA & PMT department. Prepare Standard Operating Procedures (SOPs) for the Department.Preparation of Periodic Safety Update Report (PSUR) as a part of Pharmacovigilance. Ensure the Project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations. Show less

      • Assistant General Manager

        Apr 2024 - now

      • Senior Manager

        Jan 2023 - May 2024

      • Manager Clinical Trial and Medical Writing

        Jan 2022 - Sept 2023

      • Deputy Manager Medical Writing

        Jan 2020 - Jun 2022

      • Research Scientist-1 - Medical Writer

        Jan 2018 - Jan 2020

      • Medical Writer - Research Associate

        Jun 2016 - Dec 2017

  • Licenses & Certifications