Shreekrishna Krishna Parpani

About Shreekrishna Krishna Parpani

Enthusiastic, flexible, and innovative regulatory medical writer with 11 years of progressive career track and outstanding record of accomplishments in the field of clinical research and medical writing-Experienced in US FDA and EMA submissions along with other country specific submission-Experience of regulatory writing, across various therapeutic areas (oncology, diabetes, genetic disorders, cardiovascular and metabolism, ophthalmology, respiratory, infectious diseases and transplantation, neurology, etc.), and across phases of drug development (early development, clinical pharmacology, translational oncology, clinical development, global medical affairs)-Detail-oriented writer with a commitment to accuracy and efficiency-Possess broad experience of working with number of multi-functional teams to achieve organizational objectives-Knowledge of modern writing and editing styles-Consistently rewarded for success in planning and operational improvements-Excellent reputation for resolving problems, improving customer satisfaction, and driving overall operational improvements-Experienced in mentoring/coaching medical writers and resource management.Specialties: Clinical Study Report (CSR), CSR Addendum and Amendment, Clinical Trial Protocol, Protocol Addendum and Amendment, General Investigational Plan, Module 2.2 Introduction to Summaries, Pediatric Investigation Plan (PIP), Module 2.5 Clinical Overview, Module 2.7.1 Summary of Biopharm Studies, Module 2.7.2 Summary of Clin Pharm Studies, Module 2.7.5 References, Module 2.7.6 Synopses of Individual Studies, Module 5.2 Tabular Listing of All Clinical Studies, Module 5.4 Literature References, Briefing Document, Risk Profile, Regulatory Response-High Complexity, Development Safety Update Report (DSUR), Addendum to Clinical Overview (ACO), Responses to Health authority questions, Investigator’s Brochure (IB), Device IBs, Investigational Medicinal Product Dossier (IMPD), Investigational New Drugs (IND), China population pharmacokinetics report, Patient safety narratives, scientific writing, and clinical research.

Experience

1. Manager Ii, Crew

   AstraZeneca

   Apr 2024 — Present · Bengaluru, IN

Education

• Attar Singh Yadav Memorial Education Trusts Siddhant College of Pharmacy,Pune

  Bachelor of Pharmacy - BPharm, Pharmacy

  2008 — 2012

• Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune

  Master of Pharmacy, Pharmaceutics and Drug Design

  2012 — 2014

Skills

• Clinical Research
• Patient Safety Narratives
• Market Research
• Regulatory Affairs
• Gcp
• Statistics
• Data Analysis
• Investigator’s Brochure Update
• Gmp
• Pharmaceutics
• Development Safety Update Report
• Quality Assurance
• Microsoft Office
• Pharmacology
• Medical Writing
• Spss
• Hplc
• Clinical Trials
• Powerpoint
• Microsoft Excel
• Pharmaceutical Sales
• Pharmaceutical Industry
• Sop
• Marketing Communications