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Male, 57 years, born on 22 June 1968
Moscow, willing to relocate, prepared for business trips
Medical Affairs and Clinical Research
Specializations:
- Physician
Employment type: full time
Work experience 33 years 5 months
August 2021 — currently
4 years 10 months
ООО "Вита этерна"
Moscow
Head of clinical operations
Planning of the functional lines activities
• Control of the Goals’ achievement
• Customer Relations Development and Maintenance
• Governmental Relations
• Clinical Research and Regulatory Staff management
• Maintenance of the high Quality Standards of the company performance (no critical observations during sponsors’ audits
March 2016 — currently
10 years 3 months
RD1
Moscow, www.rd-1.ru
Medicine, Pharmaceuticals, Pharmacies... Show more
Director for Clinical Research and Registration
• Planning of the functional lines activities
• Control of the Goals’ achievement
• Customer Relations Development and Maintenance
• Governmental Relations
• Clinical Research and Regulatory Staff management
• Maintenance of the high Quality Standards of the company performance (no critical observations during sponsors’ audits
November 2019 — June 2021
1 year 8 months
OAO Sintez
Chief Medical Officer
New product introduction
Pharmaceutical development of the company pipeline products
Pre clinical and clinical research
State registration and GR
December 2013 — February 2016
2 years 3 months
Russia, www.alfawassermann.ru/
Medicine, Pharmaceuticals, Pharmacies... Show more
Medical affairs manager
Medical support to promotion activities, local clinical trials, relations to medical and scientific communities and National Opinion Leaders. Promotion Material review and approval.
June 2011 — January 2013
1 year 8 months
Bausch & Lomb
Moscow
Medical Manager
Key Responsibilities
Building relationships with country OLs, via implementation of local publication policy, setting up specialized Advisory Boards, company sponsored symposia within local and international Congresses
Organisation and supervision of Local Clinical Trials,
Implementation and maintenance of Quality Standards, by setting up core local SOPs;
Review and approval of the third party lectures and lecturers
Participation in the development and approval of promotion materials;
Preparation and conduct of trainings for B&L and the partners employees;
Ethics and Company Code of Conduct Compliance surveillance
Local Qualified Person for Pharmacovigilance.
March 2010 — June 2011
1 year 4 months
Maxwell Biotech Venture Fund
Managing Director
Responsible for (i) developing strategic partnerships between the firm's portfolio companies and other international companies and financing sources, (ii) negotiating the terms and structure of the funds investments, (iii) overseeing the management of all portfolio company investments, and (iv) overseeing due diligence on all potential investments.
March 2004 — January 2010
5 years 11 months
Abbott Laboratories
Medical Manager
Type of employees:
Medical Advisers; Clinical Research Associates.
Description of duties and responsibilities:
Clinical Research
Supervision of Clinical research activities, including phase III-IV clinical trials, Investigator initiated studies, and post-marketing observational projects. Budget management.
Preparation, review and approval of local clinical studies, CRO management.
Medical Affairs:
Development, Review & Approval of promotional materials and local scientific publications; medical Information co-ordination & field force training; regulatory activities related to State registration, clinical research and reimbursement programs.
Pharmacovigilance:
Safety surveillance/reporting/Training.
Quality Assurance
Affiliate audit management (audit co-ordination), Evaluation of local manufacturing Sites (GMP-audit);
GCP compliance audit of Clinical Sites and CRO in-house documentation.
Development and maintenance of local SOPs, Working Instructions and Policies
January 2001 — January 2004
3 years 1 month
Moscow, pfizer.com/careers/
Clinical Research Manager
Type of employees:
Clinical Research Associates.
Description of duties and responsibilities:
Clinical research (planning, conduct and supervision of phase II-IV studies and IMGs); Review and Approval of Local Clinical Study proposals; Investigators education; Management of CRA performance, Clinical Supplies Co-ordination; Regulatory approval, Safety surveillance/reporting; Training.
January 1997 — January 2001
4 years 1 month
IBAH International
Clinical Research Associate
Start up conduct and completion of international clinical trials
January 1992 — January 1997
5 years 1 month
Experimental Immunology Research Institute
Physician
First postgraduate student then practicing physician
Skills
Skill proficiency levels
About me
Clinical research,
Quality Assurance
MedicaL affairs
Audit,
Budget planning and management
Higher education
2019
Higher education
MIRBIS
EMBA
1997
Higher education
Experimental Immunology Research Institute
Endocrinology
1992
Higher education
Moscow Medical Stomatology Institute
GP
Languages
Citizenship, travel time to work
Citizenship: Russia
Permission to work: Russia
Desired travel time to work: Doesn't matter
