Medical affairs manager or Medical director

Описание


Name: Alla Khrykina
Date of Birth: 13 October, 1968
Telephone: +7-499-150-01-38 (home), +7-903-543-1220 (cell)
E-mail: alla032@yandex.ru

I am an experienced medical doctor, now specializing in the pharmaceutical medical affairs. I am interested in the position of Medical affairs manager or Medical director
Education:
1982-1988 Orsk State Nurse-training School.
1988-1994 Orenburg Medical Institute, General Practitioners Department. Specialty: General practitioner.
1994-1995 Internship as a general practitioner at the City Hospital #1, Novotroitsk, Orenburg Region.
1998-2000 Residency at the Chair of Nephrology and Hemodialysis of the Russian Medical Academy for Post-graduate Training. Specialty: Nephrology.
2007-2010 Sechenov Moscow Medical Academy, postgraduate training course “Interpreter in medical communication”
Additional education:
2001 training course on transfusiology with a certificate and a permission to work with donor blood and blood supplements.
2003 training course on osteoporosis with a certificate.
2005 training course on modern intensive care (CPR,etc.) with a certificate.
2007 training course on «Introduction to GCP» with a certificate.
2011 Advanced course on GCP with a certificate
2012 training courses of management
2013-2015 training courses of medical writing skills and scientific publication
2020 - online course on Literary review in the CTD format according to the EAEU requirements (Sciencefiles company) with a certificate

Professional Experience
07.12.17 up till now - Dr. Willmar Schwabe GmbH & Co. KG
Position: Medical affairs manager
Responsibilities:
• Creation and implementation of Medical strategy for each group of products reflecting on a deep understanding of HCPs’ and patients’ needs
• Maximization of value through effective, on-time evidence generation, leading to strong medical messages
• Explore New Therapeutic Areas for old products in the frame of existing indications
• Pre-launch Medical-Scientific activities and fully medical support of all Launch activities
• Create Product Scientific Knowledge Center for external and internal customers
• Deliver Trainings and Core Deliverables to Field Force
• Integrated, well-coordinated medical activities across functions
• Medical-scientific support Registration activities & PV for business continuity
• Medical risk-management by controlling promo-materials according PILs, published scientific data, local legislation and ethic principles
• Drive and implement Lean Procedures & Systems
• Initiation and implementation Patient support programs
Experience:
• Medical strategy contributing to overall portfolio, supporting Marketing strategy have been created
• Сreation of a system for POS approval
• Initiation and conduction clinical studies of urology and probiotic products with publication the results
• Development of the system of continue medical product education for the FF
• Initiation of the Product Scientific Knowledge Center for external and internal customers
• Preparation and implementation of the SOP for interaction with KOLs

04.12.12 to 04.12.17 - Abbott Laboratories
Position: Senior Medical Adviser of Cardio-metabolic (Physiotens, Omacor and Tricor) and Ophthalmology (Xalatamax, Blink) products
Responsibilities:
• Contribute medical, clinical expertise and scientific advice for cardio-metabolic and ophthalmology products lines
• Provide medical input directly to the development of scientific and medical education messages and materials
• Review and approve promotional materials, in accordance with regulatory requirements and local legislation
• Provide medical leadership in training programs for the commercial teams and other functions
• Support cross-functional teams in patient-focused activities
• Create and fulfill Clinical Development Plan in collaboration with Clinical research group
Experience:
• Creation and realization the medical strategies for cardio-metabolic and ophthalmology products
• Successful implementation of pre-launch and launch medical activities of the Blink and Xalatamax products lines
• Performance Webex education medical product courses of all products for new employees
• Start up 2 IISs Physiotens and support them; start up IIS Tricor; start up PMOS Xalatamax

01.08.2011 to 01.12.12 – Janssen Pharmaceutical Company of Johnson&Johnson
Position: Medical Adviser (1 MSL was reported).
Responsibilities:
• Contribute medical, clinical expertise and scientific advice for virology product lines (Prezista and Intelence)
• Collaborate effectively with Regional and Global Teams in the execution of relevant clinical activities
• Work as strategic partner with Marketing for the development of projects and marketed products in virology
• Plan, initiate, manage the implementation and drive timely publication activities
• Create and fulfill Clinical Development Plan and in collaboration with GCO advise/recommend potential investigators for local and global studies
• In collaboration with PMs create and review promotional and training material.
• Provide comprehensive product/disease and therapies presentations and training to internal and external customers, incl. the field force, for the accurate delivery of messages in line with global plans
Experience:
• Creation and realization of the medical strategy in virology products, including pre-launch medical activities
• Preparing Medical Affairs Plan for the launch of new products
• Working out the scientific content of satellite symposiums of 12 national Congresses and support of the Russian KOL’s lecture in the International Congress in Belgrade
• Preparing Advisory board with international and federal KOLs in Paris and 2 local Advisory boards in Moscow
• Initiation of clinical study (IV phase, non-interventional) included 20 sites and 400 pts

09.04.2008 to 29.07.2011. ZAO Fresenius S.P. (Fresenius Medical Care, Germany)
Position: 01.06.10 - 29.07.2011 Medical Adviser
09.04.2008 - 30.06.2010 Product Manager Peritoneal Dialysis
Responsibilities:
• medical research of special group of medical products (nephrology), collecting and analysis the information of competitors
• preparing and conducting registration and post-marketing clinical studies
• realization of special medical and education programs and control their efficiency
• information support of sales (the preparation of presentations, consultation on clinical application of products, organization of products approbation), preparation of lectures, scientific articles, promo-materials
• development of the cooperation with OLs and bridging with patient organizations
• collection information, analysis and reports on adverse effects of the products; the work with complaints of clients (filling in Complaint Reports and answers customers)
• support and cooperation with Legal Aspects Department (preparation texts of instructions for medical use of medicine and PSUR) and Logistic Department
Experience:
• 13% increase in the market share by the expansion into the new regions and into the competitor territory in 2010.
• Initiation of IPOD-PD International study (IV phase) and local clinical study (III phase)
• Successful effort to attract of new clients by the high service of product using the creation and coordination of application specialist’s team's work.
• Holding product trainings for group of doctors and nurses in Moscow and St.-Petersburg clinics
• Successful realization of education program for patients “Kidney Options”; extensively supported specialists with the software “PatientOnLine “(a powerful tool to improve therapy management) and some other projects in order to increase of clients loyalty.

29.06.2007 to 08.04.08 Pharmaceutical Company “PHARMAPARK” (Russia).
Position: Clinical Trial Manager
Responsibilities:
• Planning and conducting clinical trials according to GCP and company SOP’s, standard requirements at CR and at national level.
• Investigator selection and motivation. Study initiation, including monitoring, study surveillance (planned patient enrolment, timeframes and quality assurance). Handling medication.
• Financial negotiations with investigators including financial agreements with investigators, budget surveillance and payment.
• Information and support to investigators.
• To build and maintain good relationships with external (e.g. investigators, Health authorities, etc.) collaborators.
Experience:
• Created design of the Clinical Research and developed Clinical Research Protocol, and the other necessary documents the clinical trial
• Obtained the permit of health authorities and approval of Ethical Committee to the clinical trial
• Chosen appropriate clinics for the clinical trial and adjusted conditions for realization of the clinical trial in them.
• Initiation of the clinical trial including 200 patients in 4 sites (in 2 large Moscow clinics, in Samara and in Volgograd).
• Conducted monitoring of the clinical trial.

19.10.2005 to 27.06.2007 Pharmaceutical Company “Advanced Trading” (India)
Position: Marketing Manager (antituberculous drugs)
Responsibilities:
• market research of antituberculous drugs
• cooperation with OLs
• information support of sales (preparation of lectures, promo-materials)
• support of Legal Aspects Department (preparation of texts of instructions for medical use of medicine and PSUR)
Experience: obtaining skills of marketing and medical support of sales.

01.09.2000 to 18.10.2005 Botkin State Clinical Hospital. (Russia, Moscow).
Position: Nephrologist
Responsibilities: treatment of in-patients, intensive care of urgent cases, night duties, consultations to different departments of the hospital
Experience:
• Having worked for a multi-purpose intensive-care hospital
• Has fully mastered the skills of a general practitioner
• Selected patients for clinical trials
• Performed laboratory and clinical control during clinical trials
In 2001 received a qualification of a 1st grade medical doctor.

1995-1998 City Hospital #1, Orenburg Region, Russia.
Position: General practitioner with a cardiology department
Responsibilities: treatment of in-patients and of out-patients, duties at an intensive-care department.
Experience:
• Obtained of professional skills
• Initial expert assessment of patients

Additional information: Upper-Intermediate English, good PC user.
Permanent domicile registration: Moscow
Personality: career-oriented, with an ability to resolve complicated problems, excellent communication skills, fast learner.