Iryna VolchykIV
Open to opportunities

Iryna Volchyk

@irynavolchyk

Experienced clinical trials coordinator with expertise in medical writing.

Israel

What I'm looking for

I am looking for a role that fosters collaboration, innovation, and professional growth in clinical research.

I am a dedicated professional with a strong background in pharmacy, clinical trials, and regulatory affairs. My expertise lies in creating clear and accurate medical documents for regulatory submissions, clinical studies, and scientific publications. I have a proven ability to transform complex scientific data into engaging and precise content, ensuring that all documentation meets the highest standards of quality and compliance.

Throughout my career, I have successfully managed clinical trials, developed drug master files, and prepared regulatory submission documents for FDA and EMA. My experience includes working with diverse teams and stakeholders, ensuring effective communication and collaboration. I am fluent in English, Hebrew, Russian, and Ukrainian, which allows me to translate and localize medical content effectively. I am passionate about contributing to advancements in healthcare through my work in clinical research and regulatory affairs.

Experience

Work history, roles, and key accomplishments

ZC
Current

Clinical Trials Coordinator

Ziv Medical Center

Nov 2023 - Present (1 year 6 months)

Responsible for managing clinical trials, including medical writing of study documents, data management, and ensuring regulatory compliance.

UQ

Chief Expert Regulatory Affairs

Ukrainian Scientific Pharmacopoeia Center Drug Quality

Sep 2009 - Feb 2015 (5 years 5 months)

Developed pharmacopoeial monographs, worked on regulatory documents, and contributed to international publications.

J‘

Chief Editor

Journal ‘Pharmacist’

Jul 2007 - Jul 2009 (1 year 11 months)

Managed the scientific content of the journal, coordinated the editorial process, and provided scientific editing and writing.

PZ

Regulatory Affairs Manager

Pharmaceutical Company Zdorovia

Sep 1999 - Jul 2006 (6 years 10 months)

Developed drug master files for FDA submissions, handled regulatory documentation, and supported pharmacovigilance activities.

Education

Degrees, certifications, and relevant coursework

NU

National Pharmaceutical University

PhD, Pharmacology

2002 - 2006

VU

V. N. Karazin Kharkiv National University

Master of Science, Biology

1992 - 1997

Tech stack

Software and tools used professionally

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Iryna Volchyk - Clinical Trials Coordinator - Ziv Medical Center | Himalayas