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Profile Details

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USD 50 /hr

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Hire Naresh S.

India

USD 50 /hr

Medical and Scientific Writing || Clinical Research || Drug Safety || Scientific Editing || Scientific Consultant ||

Profile Summary

Regulatory Writing: Clinical Study Report, HA Responses, Literature reviews, Narrative writing, NDA-AR, IND-AR, CO and NCOs, Protocol, Investigational Brochure, IND applications, MAH applications and Medical Information query responses.
 Safety Writing: Aggregate Safety Reports [PSUR, PBRER, PADER, DSUR, ACO, CAR], ICSRs, Signal Management and PV Quality Assurance 
Clinical Writing and communication (Drug development profiles, clinical study results analysis, drug pipeline analysis, case reports and narratives
Preclinical research
Details: 	
Regulatory writing: Authoring, review and coordination for CSR, IB, Protocol, CO and NCOs, IND-AR and other documents supporting clinical development across therapeutic areas. 
 Experience across different therapeutic areas and development stages.
 Review and submission of regulatory documents to different regulatory agencies (US FDA, Health Canada and EMA) and to the Ethic Committees.
 Safety Writing and RA: PRAC, RMP, PSUR, CCDS, Labelling updates for different EU and the US clients
 Setting up Regulatory Intelligence process
 Labeling Justification Documents for supporting changes to CCDS sections 4.8 and 4.9.
 Label update project for the US market (Updating current prescribing information in response to innovators labels)
 Drug Development Profiles and drug pipeline updates (Competitive/Market intelligence/ Market Research).
 Narrative writing and literature reviews

Subject Matter Expertise

Services

Writing
Research

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Fact Checking, Systematic Literature Review, Secondary Data Collection

Work Experience

Assistant Manager, Quality (Scientific Writing & Regulatory Affairs)

Covance

July 2017 - Present

Lead Quality Specialist

Sciformix - A Covance Company

January 2017 - June 2017

Senior Quality Specialist

Sciformix - A Covance Company

January 2016 - January 2017

Senior Medical Writer & Project Coordinator

Sciformix - A Covance Company

November 2015 - January 2016

Senior Scientific and Medical Writer I

Springer Nature

September 2013 - October 2015

Medical Writer

Sciformix - A Covance Company

July 2011 - September 2013

Pharmacovigilance Associate

CDSCO

January 2011 - June 2011

Pharmacy Technician/Dispenser

ABC Pharmacy, London

September 2008 - October 2010

Research Associate

Biopta Ltd, Glasgow

February 2008 - September 2008

Education

Masters in Pharmacology

glasgow caledonian university

September 2007 - October 2008

Bachelors of Pharmacy

Pune University

July 2003 - July 2007

Certifications

Certification details not provided.