Maria Semashko Email & Phone Number

Москва, Россия

Planning and support of clinical trials for scientific purposes and for regulatory submissions for medical devices and drugs developed by the laboratory. Preparation of dossier for IVD products and submission to authorities according to local regulatory requirements.

Москва, Россия

Preparation of dossier for IVD product for submission according to local regulatory requirements. Planning the submission strategy and the budget for regulatory submissions. Planning and support of technical and clinical trials of medical devices for in vitro diagnostics.

Moscow, Russia

Provide medical input to regulatory applications, new product development and clinical activities, and business development and acquisition initiatives. Medical information - respond to enquiries and complaints from consumers and HCPs. Development and medical approval of accurate, technically supported and business oriented claims. Coordinating evaluation and approval of promotional materials.

Medical Affairs: Provision of medical support to the internal clients of the company: the employees of the Marketing Department, the employees of the DRA Department. Ensuring compliance with internal and external applicable policies, procedures and other regulations. Clinical operations: Responsible for effectively managing and monitoring of clinical trials carried out in the Russian Federation in accordance with the international requirements, the requirements of the Russian legislation and corporate requirements and delivering on time and within budget. Provide input to top management teams to support strategic clinical trial decisions.

Москва, Россия

Therapeutic area – rheumatology and immunologyResponsible for all aspects of study site monitoring including routine monitoring visits and writing MV-reports, performing SDV, maintenance of study files, liaise with vendors, collecting information about serious adverse events (SAE) and transmitting it to the pharmacovigilance, preparing for audits. Responsible for initial stages of the clinical trial such as preparing agreements with the study sites, submissions into regulatory organizations, performing trainings for the study site staff on the initiation visits.

Therapeutic areas – cardiology, endocrinologyAssist to Clinical Research Associate (CRA) and Project Manager (PM) with obtaining necessary documentation and information from investigators before, during and after study. Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. Maintenance of study files and preparing all the documents for initiation visits. Organization of trainings for physicians and researchers.

Research activities in virology area, Laboratory of genetic engineering of viruses, MSU.

Madrid Area, Spain

Research activities in virology area.