Hamlet Simonyan

Experience

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  ClinChoice

  Jun 2018 - now

  ClinChoice is a full-service clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide. With a 25 year history of success, ClinChoice continues to be The Standard of Excellence for biostatistics, clinical operations, data management, statistical programming, CDISC, regulatory affairs, medical affairs and pharmacovigilance. ClinChoice has established major delivery centers across US, China, Europe, India, Japan and the Philippines. It has over 1,800 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe.Main Responsibilities Include:-Coordinating all interactions with the team, communicating with the Service Provider’s management and Subject Matter Expert (SME) and the Company’s management and SME,-Coordinating, planning, and evaluating project activities as defined by the project scope, goals, and deliverables,-Monitoring project deliverables metrics using appropriate tools to provide direction and support to offshore regulatory resources,-Constantly monitoring and reporting on project progress to all stakeholders, presenting reports defining project progress, problems, and solutions,-Supporting the preparation and completion of action plans, implementing production, productivity, quality, and customer-service standards, resolving problems, managing audits, and identifying trends. Show less Main Responsibilities Include:-Act as the conduit among Regulatory Operations resources, the Company’s Franchise and International Regulatory Affairs Affiliates and third parties (where appropriate) to satisfy individual country product registration requirements,-Work with the team in developing submission timelines, capacity planning, and prioritization for assigned projects,-Communicate international regulatory approvals to the local regulatory team and management,-Maintain regulatory work processes and tracking tools that improve performance levels and transparency, including filing, and traceability of all regulatory data/documentation. Show less

  • Project Manager, Regulatory Affairs

    Mar 2022 - now

  • Regulatory Affairs Specialist

    Jan 2020 - Mar 2022

  • Business Development Specialist

    Jun 2018 - Dec 2019
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  American University of Armenia

  Aug 2023 - now

  Teaching Associate
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  Yerevan State University

  Oct 2023 - now

  Scientific Researcher