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Medical Writer Regulatory Affairs

Location:
Mumbai, Maharashtra, India
Posted:
May 15, 2023

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Resume:

Namrata Bhoir

Panvel, Maharashtra, India

adw4ur@r.postjobfree.com

linkedin.com/in/namratakbhoir

Summary

A passionate medical writer with experience in medical and regulatory writing. Self-motivated, detail oriented

and professionally ready to accept challenge and passionate to embark on opportunity to improve life and create

a lasting social impact. Worked in different departments of pharma company like Production, RA and quality

assurance. Medical writing course from Henry Harvin Institute.

Experience

Associate Medical writer

SCICLINICA services

Dec 2022 - Present (5 months)

To prepare and review Protocol, ICF, Clinical Study Reports, ensuring correctness, accuracy and

compliance.

To prepare PSUR, RMP, CTD module 2.4,2.5,2.6 and 2.7.

Ensure all activities are performed as per agreed project timelines.

Medical writing intern

Henry Harvin

Sep 2022 - Dec 2022 (4 months)

Senior Quality Assurance Officer

Kopran Ltd

May 2012 - Jan 2015 (2 years 9 months)

Education

Global institute of regulatory affairs

Regulatory affairs certification, regulatory affairs

2012 - 2012

Sinhgad Institute of Pharmaceutical Sciences, Lonavala

Bachelor of Pharmacy, Pharmacy

2005 - 2009

Henry Harvin

Medical writing

Aug 2022 - Sep 2022

Namrata Bhoir - page 1

Licenses & Certifications

certified medical writer - Henry Harvin

Skills

Regulatory Affairs Microsoft PowerPoint Clinical Research Decision-Making Microsoft Excel

Teamwork Microsoft Word English Leadership Microsoft Office

Namrata Bhoir - page 2



Contact this candidate