Iryna Volchyk
@irynavolchyk
Experienced clinical trials coordinator with expertise in medical writing.
What I'm looking for
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
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.
Clinical Trials Coordinator
Rambam Health Care Campus
Jan 2023 - Jan 2024 (1 year)
Managed clinical trials, developed master files, communicated with study centers and ethical committees, and translated study documents.
Grant Visitor
Technion
May 2022 - Jul 2022 (2 months)
Conducted analytical development for drug targeting and delivery in cancer research, contributing to scientific publications.
Senior Research Assistant
Medical Academy of Postgraduate Education
Feb 2015 - Apr 2022 (7 years 2 months)
Managed clinical trials, data management, and provided medical writing support for clinical research.
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.
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.
Regulatory Affairs Manager
Biolic
Aug 2005 - Jul 2007 (1 year 11 months)
Managed new applications and life-cycle management for biologic drugs and small molecules worldwide, including FDA drug master files.
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.
Laboratory Doctor
State Medical Genetic Center
Feb 1997 - Jan 1999 (1 year 11 months)
Worked as a laboratory doctor focusing on genetic testing and analysis.
Education
Degrees, certifications, and relevant coursework
National Pharmaceutical University
PhD, Pharmacology
2002 - 2006
V. N. Karazin Kharkiv National University
Master of Science, Biology
1992 - 1997
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Salary expectations
Job categories
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