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Curriculum Vitae

informatii personale

 

F 09.02.1977

obiectiv

 

The medical director participates in administrative decision making and recommends and approves policies and procedures,organizes and coordinates services provided by other professionals as they relate to patient care,participates in the development and conduct of educational programs,acquires, maintains, and applies knowledge of social, regulatory, political, and economic factors that relate to patient care services.

Salariu: nespecificat

Tip job: Full time

Departament: Medicina umana, Farmacie, Cercetare - dezvoltare, Management

Oras de lucru: Bucuresti

Nivel Cariera: Manager / Executiv

Disponibil: oricand

experienta profesionala

 

01.08.2012 - prezent

Departament: medicina umana

Titlu Job: medical director , member of compliance committee,apmgr representative

Responsabilitati:

Highlights of activity:
Created medical department in the company, with processes, procedures, KPIs, strategy, and passed ISO9001 certification
Medical and compliance governance of all activities involving communication to medical community or patients
Raised the ethical standards in medical activities to build up company reputation
Represented company interests in APMGR in respect to key aspects (clawback, pricing, reimbursement)

01.08.2010 - 01.08.2012

Departament: farmacie

Titlu Job: medical affairs therapeutic manager oncology

Responsabilitati:

Highlights of activity:
Create and executed annual medical brands/franchise strategy
Managed budgets
Developed KOLs advocacy
Supported premarketing activities (clinical trials, medical reimbursement files )
Granted the ethical and scientific standards of the medical communication and promotional materials
Passed internal audits

19.03.2007 - 02.09.2010

Departament: farmacie

Titlu Job: product manager

Responsabilitati:

1. Define the product strategy and roadmap
2. Deliver MRDs and PRDs with prioritized features and corresponding justification
3. Work with external third parties to assess partnerships and licensing opportunities
4. Run programs with early-stage products and samples
5. Be an expert with respect to the competition
6. Act as a leader within the company

19.03.2003 - 19.03.2007

Departament: farmacie

Titlu Job: sales representative

Responsabilitati:

In consultation with my supervisor, organize and lead events (mini-symposia, local events, evening meetings personal presentations) for healthcare professionals. During these events, make product presentations, prepare the speaker, lead discussions and answer questions in a highly professional manner so as to promote product use and enhance the Company’s image. Also actively help to organize regional and national symposia as required.
Target and establishe a close liaison with all opinion leaders and meet with them individually on a regular basis for discussions in line with the approved promotional plans and achieving the meeting objectives.
Analyse market and sales data to monitor competitive developments and to determine regional product developments and opportunities and make appropriate submissions and recommendations to management.
Monitor the delivery of goods to ensure timely availability of Company products.
Provide timely feedback to Marketing on the impact of - and customer reaction to – promotional literature and other marketing materials.
Develop and maintain an up-to-date Customer card index, containing comprehensive records of customers, product presentation and visit results and use the information for short and long term customer development.
Assist Customer Services to resolve field related customer problems.
Use product samples and promotional gifts according to promotional plan, aimed at achieving positive results with the customer.
Carrie out special information / intelligence gathering projects as required in support of Marketing strategies and plans.
Maintain regular contact with MSD colleagues to ensure an effective exchange of important information and a uniform representation of the Company’s interests.
Through ongoing training and study of technical literature, promotional literature and other relevant documents, the job I remain up-to-date on all matters pertaining to my professional responsibilities.
Undertakes any other assignments as directed by direct supervisor and/or Country Manager.

studii

 

Facultati:

2009 - 2009 Masterat: MBA la MBA British Academy of Bussiness and Comunication -2009 din Bucuresti. Bussiness Marketing
Bussiness Communication
Advertising and PR
Organizations, Contracts and Comercial Operations
Banking
1997 - 2003 Facultate: Sthomatology la Medicine University “Carol Davila” Bucharest, 2003 din Bucuresti.

Premii

Certificari
Apr 2014 - Apr 2014: Seminar of local legal aspects in pharma industry- TZA tax experts and legal advisors 2014
Principal subjects/Occupational skills covered:
• Major aspects of law nr. 95/2006 and secondary medicine law
• Clawback taxation and impact
• Legal frame that regulates patients access to reimbursed therapies
• Parallel trade and competition
• Incidents in economic activity of pharma companies: fiscal inspection and insolvency
Mar 2014 - Mar 2014: Pharma Law Convention 2014- European panel of experts
• Legal pharma environment,
• Parallel trade
• Clinical trials
• Competition law
• EFPIA transparency rules
• Patients access to medicine
• A European Medicines Verification System
• Taxation of pharmaceutical market: legal challenges in Romania
• Good Distribution Practice (GDP)
• Data Privacy
• Cross-Border HCP Engagements
Jan 2013 - Jun 2014: Clinical Development and ComplianceTraining Record
1. Documentum: Viewing and Reviewing in CephDocs
2. Requesting a Program/Study Number and Centrally Registering Company Sponsored/Supported Programs
3. Handling and Reporting Adverse Events and Adverse Drug Reactions for Teva Products
4. Clinical Study Monitoring/Co-Monitoring Plans

5. Overview of the Clinical Research Process
6. GCP11 Overview of the Clinical Research Process
7. Handling Safety Information on Company Products
8. Informed Consent
9. PhV New Procedures for Future Studies
10. Phase IV Coordination
11. Centralized Activity Review and Evaluation (CARE)
12. Fair Market Value
13. Antitrust and Competition Compliance
14. Investigator Selection for Clinical Studies
15. Transfer of Clinical Trial Subjects between Study Centers
16. Global Process for the Selection and Management of Third Party Services and
17. Global Request and Approval of Randomization Codes for Clinical Trials
18. Global Investigator Selection
19. Global Process for Clinical Study Protocol
20. Global Process to Develop the Safety Monitoring Plan for a Cephalon Sponsored
21. Return and Destruction of Investigational Products
22. Global Process to Develop and Maintain Investigator's Brochure
23. Default SOP Affecting Clinical Research and Associated Role/Function Changes
24. Global Development of Informed Consent Form
25. Evaluation and Management of Protocol Exceptions and Violations
26. CRO - Vendor(s) Oversight and Management
27. Global Statistical Analysis Plan, Preparation, Review and Approval
28. Generation of Database Specifications and Case Report Forms
29. Assess Potential Urgent Safety Issues and Implement Urgent Safety Measures in a
30. Global Coding of Medical Terms
31. Managing Database Lock and Unlock Procedures
32. Global Procedures for Maintaining and Breaking the Blind for a Clinical Study
33. Developing the Data Review and Medical Interpretation Report for Clinical Study
34. Creation, Maintenance and Closure of the Trial Master File for Worldwide Clinical Studies
35. Global Interim and Final Analysis Procedures
36. Terminating the Participation of an Investigator in a Clinical Trial for
37. Global Statistical Input to Clinical Trial Protocols
38. Global Process for Clinical Study Report
39. Request for Shipment of Investigational Product to Clinical Investigator Sites
40. Global Pre-Study Site Visit for Assessment of a Proposed Clinical Study Site
41. Registration and Results Posting of Clinical Trials
42. Registration and Results Posting of Teva-Sponsored Studies
43. Scientific Meetings
44. Clinical Study Protocol
45. Managing Database Lock and Unlock
46. Global Publication Policy
47. Generation of Database Specifications and Case Report Forms
48. Development and Maintenance of the Investigator's Brochure
49. Training Management and Documentation
50. Coding of Medical Terms
51. Investigator Sponsored-Studies
52. Clinical Study Report and Clinical Summaries
May 2012 - May 2012: Principles of Clinical Research-Protocol Design Series
provide a foundation in the essential elements of well- constructed clinical research protocols and how these elements are applied in clinical trials and observational studies.
Apr 2012 - Apr 2012: Training for How to Respond to Professional Information Requests (PIRs)

Dec 2010 - Dec 2010: Clinical study rapport Writing Seminar (Integrated Process)
Principal subjects/Occupational skills covered:
 Define the purpose of a CSR
 Explain the process for managing a Clinical Study Report
 Planning
 Authoring
 Reviewing & Approving
 Distributing
 Identify roles and responsibilities associated with these activities
 Define metrics,Identify relevant resources
Dec 2010 - Dec 2010: GCP (Good Clinical Practice)
Clinical trials – international standards and guidelines Name and type of organisation providing training: Sue Fitzpatrick, Head of Education and Training, Director ofThe UK Institute of Clinical Research
Nov 2010 - Nov 2010: OR/HTA Training
Clinical trials – outcome research / health technology assessement
Sep 2010 - Sep 2010: MISP_RC Review & Decision of Research Proposal
Clinical trials – Initiating and approval process for clinical development projects
Sep 2010 - Sep 2010: Medical Legal Training
Principles of creating and legal approval of promotional materials and medical communication
Mar 2008 - Mar 2008: Marketing in Action (MMIA)
Defining and creating new marketing strategies based on pharma marketing principles
Sep 2007 - Sep 2007: Marketing in Practice (MMIP)
Marketing principles in pharma industry
Feb 2003 - Feb 2003: Evidence Based Medicine
analizyng medical data based on Evidence Based Medicine
Jan 2003 - Jan 2003: High Impact Communication

aptitudini

 

Limbi straine(Scris,Vorbit,Citit):

engleză(avansat,avansat,avansat)



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