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Naresh S. に連絡

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プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Naresh S.に依頼

India

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

プロフィール概要

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

専門分野

サービス

Writing
Research

Writing Clinical Trial Documentation, Technical Writing

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

職務経験

Assistant Manager, Quality (Scientific Writing & Regulatory Affairs)

Covance

7月 2017 - 現在

Lead Quality Specialist

Sciformix - A Covance Company

1月 2017 - 6月 2017

Senior Quality Specialist

Sciformix - A Covance Company

1月 2016 - 1月 2017

Senior Medical Writer & Project Coordinator

Sciformix - A Covance Company

11月 2015 - 1月 2016

Senior Scientific and Medical Writer I

Springer Nature

9月 2013 - 10月 2015

Medical Writer

Sciformix - A Covance Company

7月 2011 - 9月 2013

Pharmacovigilance Associate

CDSCO

1月 2011 - 6月 2011

Pharmacy Technician/Dispenser

ABC Pharmacy, London

9月 2008 - 10月 2010

Research Associate

Biopta Ltd, Glasgow

2月 2008 - 9月 2008

学歴

Masters in Pharmacology

glasgow caledonian university

9月 2007 - 10月 2008

Bachelors of Pharmacy

Pune University

7月 2003 - 7月 2007

認定資格

認定資格の詳細は未入力です。