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Profile Details

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USD 80 /hr

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Hire Girish Hirpara

India

USD 80 /hr

Freelance Medical Writer / Expert in Medical Device with 14 Years of Experience in Clinical Research (MDR Expert)

Profile Summary

An accomplished, versatile, results-oriented clinical research professional with over 14 years of experience in the Pharmaceuticals & Medical Device industries who brings strong leadership to all aspects of a clinical Research. Experience includes Medical Writing for both domestic and international markets for Medical Device and Pharmaceuticals Industry, cross-functional leadership, and outstanding value proposition development and delivery as a leader in organizations of varying size and complexity. Involvement in a number of large and small clinical research projects across multiple therapeutic areas. Mentoring and training are a large component of many research projects. Ensuring compliance with the local regulatory, ICH-GCP, MEDDEV 2.7.1/Rev 4, EU MDR 2017/745, EU IVDR 2017/746, ISO- 14155, ISO10993-1, NIOSH Submission, SOPs, and any other applicable regulations.
Medical Writing Includes (Clinical Evaluation Report (CER), Biological Safety Evaluation, Biocompatibility, IVD PER, Trial Protocol, PMCF, PMS, CIP, ICF, CSR, IB, PSUR, DSUR, PBRER, Manuscripts, Journal Articles, Literatures Systematic Review Analysis, Meta-Analysis and Scientific Documents).

Subject Matter Expertise

Services

Writing
Scientific consulting
Clinical Evaluation Report
Secondary Research
Statistical review
Editing

Literature search Deep dive into topic, Gap Analysis, Bibliography, Science-based recommendations

Editing Content editing, Proofreading

Statistical review Verify statistical analysis, Conduct simple analysis

Writing Medical Writing, Journal article, Scientific report

Secondary Research Literature search, Deep dive into a topic

Work Experience

Medical & Scientific Writer

Freelance Medical & Scientific Writer

November 2018 - Present
Sr. Manager Clinical Affairs

Biotech Vision Care Pvt Ltd

January 2017 - November 2018
Clinical Project Manager

Meril Lifesciences Pvt Ltd

March 2015 - January 2017
Sr. Executive Project Management

GVK Biosciences Pvt Ltd

June 2013 - March 2015
Asst. Manager Clinical Operation

Cadila Pharmaceuticals Pvt Ltd

April 2011 - June 2013
Sr. CRA

BA Research India Ltd

December 2006 - April 2011

Education

B.Pharmacy

Gujarat University

February 2002 - June 2006

Freelance Medical Writer / Expert in Medical Device with 14 Years of Experience in Clinical Research (MDR Expert)

Medical & Scientific Writer

Freelance Medical & Scientific Writer

Sr. Manager Clinical Affairs

Biotech Vision Care Pvt Ltd

Clinical Project Manager

Meril Lifesciences Pvt Ltd

Sr. Executive Project Management

GVK Biosciences Pvt Ltd

Asst. Manager Clinical Operation

Cadila Pharmaceuticals Pvt Ltd

Sr. CRA

BA Research India Ltd

B.Pharmacy

Gujarat University