Iryna Hoi
at Pharmaxi LLC- Claim this Profile
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Bio
Experience
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Pharmaxi LLC
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Poland
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Mar 2022 - Present
My job is to bring opportunities for developing the industry of clinical trials of medicinal products and clinical evaluation of medical devices in Ukraine.- initial communication with clients-negotiations regarding budgets and contracts-conducting meetings-participation in negotiations at a high level-building partner contacts and developing the company's partner network-strategic planning of the process of lead generation and marketing campaigns-management of the business development department- communication with other departments of the company- direct reporting to the CEO of the company Show less
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Sep 2021 - Mar 2022
Pharmaxi LLC is a mid-sized Contract Research Organization, operating in Eastern European countries. These countries are attractive locations for clinical trials. Pharmaxi is an efficient, client-oriented, flexible, and cost-attractive company.The main focus of Pharmaxi is the management of clinical trials (phase II-IV ) and late-phase large-scale non-interventional studies. We have rich experience in clinical research for medicines, medical devices, and IVD. Services embrace all types of activities, starting from the study design development to the final study report. If some specific tasks are not covered in-house, (e.g. drug depot, logistics, insurance), we subcontract trusted and fully-vetted local vendors. Show less
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University of North Carolina at Chapel Hill
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Research
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1 - 100 Employee
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Research Assistant
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Feb 2023 - Present
I joined the research, which is related to the study of the nature and mechanisms of corruption ties in Ukraine between oligarchs, businesses, and government officials. I have the opportunity to collaborate with Silviya Nitsova at the Department of Political Science at the University of North Carolina at Chapel Hill. It will be a difficult stage, but this work will be helpful for me as a student of the Department of Public Policy at KSE and for the future of my country. I joined the research, which is related to the study of the nature and mechanisms of corruption ties in Ukraine between oligarchs, businesses, and government officials. I have the opportunity to collaborate with Silviya Nitsova at the Department of Political Science at the University of North Carolina at Chapel Hill. It will be a difficult stage, but this work will be helpful for me as a student of the Department of Public Policy at KSE and for the future of my country.
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Auditor (Medical Device, QMS ISO 13485)
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Jan 2020 - Apr 2021
- Analyze quality systems and assess ISO 13485 and CE Marking; - Analysis of technical documentation. - Participation in audits as an involved specialist and junior auditor. - Participation in audits as an involved specialist (MD, IVD). - Evaluation and verification of documents of the Manufacturer's Technical File. - Development and preparation of the audit plan. - Development and writing of the Audit Report. - On-site and remote audit. - Analyze quality systems and assess ISO 13485 and CE Marking; - Analysis of technical documentation. - Participation in audits as an involved specialist and junior auditor. - Participation in audits as an involved specialist (MD, IVD). - Evaluation and verification of documents of the Manufacturer's Technical File. - Development and preparation of the audit plan. - Development and writing of the Audit Report. - On-site and remote audit.
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Palma Group S.A.
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Wholesale
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1 - 100 Employee
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Quality Assurance Specialist
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Apr 2020 - Oct 2020
-Support and update the quality management system under the requirements of ISO 13485 and ISO 9001. -Control of the development and development of quality management system documents: SOPs, work instructions, plans, logs, and instructions for use in the production of medical devices. -Control of the medical device registration process at all stages. -Chief Marketing Officer reporting about the current state of fulfillment of responsibilities -To maintain business relations with persons providing information and documents concerning products and objects of registration. -Negotiations with government officials and partners on the development of joint projects. -Monitoring the implementation of developers' initiatives. -Coordinate activities with the sales team. -Timely submission of proposals for the adjustment of the Position instructions of the sales staff for approval by the Company's General Director. Show less
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Cromos Pharma
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United States
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Research Services
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1 - 100 Employee
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Research Assistant (Information Analytics)
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May 2019 - Jan 2020
-Complete project activities associated with monitoring functions of Phase I-IV clinical research studies; -Assist project teams in the completion of study-specific documents, annotated CRFs, tracking forms, and other study-related documents; -Assist in the organization of Investigators' Meetings; -Interact with clients and customers. -Complete project activities associated with monitoring functions of Phase I-IV clinical research studies; -Assist project teams in the completion of study-specific documents, annotated CRFs, tracking forms, and other study-related documents; -Assist in the organization of Investigators' Meetings; -Interact with clients and customers.
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Medical device certification specialist
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Jan 2018 - Jan 2019
-cooperation with conformity assessment bodies (CAB); -cooperation with authorized representatives (AR) on the territory of Ukraine; -cooperation with the Ministry of Health of Ukraine representatives (regulation issues); -participation in international exhibitions. -communication with clients and conducting meetings -formation of the company's development strategy -working with technical documentation of manufacturers of medical devices - preparation of a package of documents for medical devices (self-declaration procedure) - performance of the duties of the Authorized Representative of the Manufacturer of medical devices in Ukraine. Show less
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Biology and Chemistry Tutor
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Sep 2016 - Aug 2018
This was my early work experience. I worked with small groups of teenagers and had the following responsibilities: - organization of the curriculum and agreement with the school management -planning of the training program and training materials - conducting classes and practical lessons in Chemistry and Biology - tutoring support for students -participation in organizational measures of administration This was my early work experience. I worked with small groups of teenagers and had the following responsibilities: - organization of the curriculum and agreement with the school management -planning of the training program and training materials - conducting classes and practical lessons in Chemistry and Biology - tutoring support for students -participation in organizational measures of administration
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Education
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Kyiv School of Economics
Master's degree, Public Policy and Governance -
Taras Shevchenko National University of Kyiv
Master's degree, Human physiology -
Kyiv National Taras Shevchenko University
Bachelor's degree, Human and animal physiology