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Hire Girish H.

India

USD 90 /hr

Freelance Medical Writer / Regulatory Expert in Medical Device with 16+ Years of Experience (EUMDR, ISO 13485, FDA510K)

Profile Summary

An accomplished, versatile, results-oriented clinical research professional with over 16 years of experience in the Pharmaceuticals & Medical Device industries who brings strong leadership to all aspects of clinical Research. Experience includes Medical Writing for both domestic and international markets for the 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 large components 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, SaMD, 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

• ★ Medical Devices
• ★ European Medical Device Regulation (MDR)
• ★ Clinical Evaluation Reports (CER)
• ☆ Biotechnology & Bioengineering
• ☆ Medical Technologies
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Device Development
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Medical Device Regulatory Consulting
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Medical Device Regulatory Writing
• ☆ Medical Writing
• ☆ Technical & Scientific Writing
• ☆ Project Management
• ☆ Risk Management

Services

• Writing
• Research
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Data & AI Statistical Analysis

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

Certifications

• EUMDR 2017/745 Course

  Qmed

  September 2020 - Present

• ISO 14155

  Qmed

  September 2020 - Present