Profile Details

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USD 50 /hr

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☆☆☆☆☆

Hire Amita K.

India

USD 50 /hr

Regulatory Writing || Medical Writing || HEOR

Profile Summary

An accomplished, versatile, results-oriented clinical research professional with over 15 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. Ensuring compliance with the local regulatory, ICH-GCP, MEDDEV 2.7.1/Rev 4, EU MDR 2017/745, EU IVDR 2017/746,US FDA 510(k) & PMA submissions, SaMD, NIOSH Submission, TGA & Other Countries regulation. 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

• ★ Regulatory Writing
• ★ Medical Writing
• ★ Technical & Scientific Writing
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Manuscript & Journal Article Writing

Services

• Writing
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Consulting Digital Strategy Consulting, Regulatory Consulting

Data & AI Data Visualization

Product Development Product Launch Support

Work Experience

Maharaja Krishnakumar Sinhji Bhavnagar University

- Present

Scientific, Medical and Regulatory writer

Freelancer

January 2021 - Present

Education

B.Sc. Biology

Bhavnagar University

April 1992 - April 1995

Certifications

• HEOR (Health Economics Outcomes Research)

  MarksMan Academy of Health Science

  May 2019 - Present

• Medical Device Regulation

  NCK Pharma Solutions Pvt. Ltd

  August 2014 - Present

• Advance Diploma in Drugs Regulatory Affairs

  NCK Pharma Solutions Pvt. Ltd

  March 2013 - Present