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Inna Leon
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English Professional working proficiency
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Ukrainian Native or bilingual proficiency
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Russian Native or bilingual proficiency
- Clinical Trials
- Logistic Support
- Ich Gcp
- Pharmaceutical Industry
- Gcp
- Show all
Bio
Credentials
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Magic of PowerPoint
LabaDec, 2021- Apr, 2026 -
Finance Management
LabaMay, 2021- Apr, 2026 -
Financial analysis and management
KURSOR, Kiev study centerDec, 2020- Apr, 2026 -
Professional negotiator course
Professional Negotiators ClubSep, 2020- Apr, 2026 -
Project management course
Spider Management Technologies UkraineDec, 2018- Apr, 2026 -
GMP/GCP/GSP/GDP:Storage and MP wholesale&Cold chain. Self-inspection&audit of pharma warehouse.
УКРМЕДСЕРТNov, 2018- Apr, 2026 -
PMI Member
PMI Kyiv ChapterOct, 2018- Apr, 2026 -
GxP: Quality system of MP distributor. Cold chain.
УКРМЕДСЕРТNov, 2017- Apr, 2026 -
Public Speaking. Complicated Negotiations.
The John F. Kennedy Institute of RhetoricOct, 2017- Apr, 2026 -
GxP. Pharmaceutical quality system. Cold chain.
STD Ltd\Стандарты Технологии Развитие ОООNov, 2016- Apr, 2026 -
Conducting of internal/external audits according to GDP/GSP and new license conditions in Ukraine
УКРМЕДСЕРТFeb, 2016- Apr, 2026 -
Validation of computer systems, standards, methodology, practice
УКРМЕДСЕРТJan, 2016- Apr, 2026 -
GMP/GDP/GSP/GCP: principals and rules. Self-inspections. Cold chain.
STD Ltd\Стандарты Технологии Развитие ОООNov, 2015- Apr, 2026 -
Pharmaceutical quality system
УКРМЕДСЕРТNov, 2015- Apr, 2026 -
Cold Chain and Validation
STD Ltd\Стандарты Технологии Развитие ОООOct, 2015- Apr, 2026 -
Manager competence: Leadership, Delegation, Motivation and Control
ШАУЗOct, 2015- Apr, 2026 -
GCP. Clinical trial regulation.
State Expert Center MoH UkraineJun, 2013- Apr, 2026
Experience
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Ukraine
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Director/Sr. Project Manager
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Sep 2015 - Present
Responsile for:Business development management: networking&negotiation with clients, coordination of sales process from proposal to contract executionSales strategy development and implementationPreparation of client's offering: proposals, RFI/RFQ and tender documentation Company budget handling and expenses control HR function (recruitment/development/evaluation/motivation of human talents) Management of logistics and depot staff Coordination of depot activity (day to day operations, expenses, improvement) Leading & executing logistics projects and work streams (preparation of project plan, instructions review, budget & contract preparation, development of distribution strategy) Projects budget control and optimization Coordination of procurement process and import/export of Medications and Clinical suppliesProjects KPI’s tracking and analysisVendor’s performance review to monitor services quality, costs and issue/deviation index Coordination of company’s QA systemEnsuring depot compliance with GxP standards and client's requirements Participation in external quality audits of subcontractors, vendors’ qualification Complaints/issues handling, root cause analysis and CAPA handlingCoordination of validation process (systems, depot equipment, premises) Product Quality Risk ManagementChange control management Coordination of internal audits performance Participation in client's and regulatory audits
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Project Manager
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Aug 2012 - Sep 2015
Responsible for:Leading and executing logistics projects and work streams (initiation, preparation of project plan, client’s requests handling, budget, scope & schedule control, project issues solving)Management of activity within company’s contractual commitments in the frame of clinical projectsManagement of logistics team and depot team supervisionManaging potential and existing customers network Preparation of commercial offers/budgets and contracts Control of payments for rendered services Performing internal and external project reportingCoordination of procurement process (sourcing and purchase of Medication and Clinical supplies) Supply chain coordination: import/export activity (Medications and Clinical supplies) Maintenance of Company’s Quality Assurance SystemParticipation in external quality audits of subcontractors, vendors’ qualification Complaint handling, route cause analysis and CAPA handlingPerforming of internal audits Participation in customer's/sponsor's audits Recruitment of new employees
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Clinical Logistics Coordinator
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Jun 2008 - Jul 2012
Responsible for:Constant communication/project issues coordination with Sponsor/sites/CRA and couriersCoordination of warehouse staff activities related to receipt and outbound shipment preparations of IMP/MP/CTMKeeping records on shipments, returns and destructionPerforming study specific trainings for warehouse staffMaintaining project files and updating on regular basisInternal project reportingControl and payments monitoring for rendered servicesParticipation in SOPs and business processes developmentParticipation in Sponsor’s/Client's auditsProject back upMaintenance of File Personnel
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Education
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2024 - 2024MIM-Kyiv Business School
Pre-MBA Business Program, Business Administration, Management and Operations -
2004 - 2009
Kyiv Economic Institute of Management
Master's degree, Foreign economic activity -
2001 - 2004
Humanitarian College
Bachelor’s Degree, Linguistics
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Industry Focus. “Pharmaceutical Manufacturing”
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