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Director Medical Affairs

16/06/2019
הגש/י מועמדות
טבע תעשיות פרמצבטיותDirector Medical, PSP and clinical operations International markets is a key leadership role within the medical affairs organization, contributing to the development and operationalization of patient centric solutions and Patient support programs (PSP’s) to improve patient experience. Ensures medical activities related to the promotion of the company's products specifically directed at the patient.

The coordination of ISSs & Phase IV studies embedded in this role is to lead and manage the investigator sponsored studies (ISS) program and tracking of the ISSs and Phase IV studies. The Director will manage, monitor and track ISS within the external web-based portal for the global intake, review and approval by the Investigational Review Committee (IRC). The lead also serves as the coordinator for the IRC and as the primary contact/manager for the ISS program and sits on the Global Medical Team with the responsibility of providing strategic input into the ISS program for a given therapy area or product.

This position includes the evaluation of proposed research concepts/proposals, management and negotiation of budgets, management of drug product supplies, forecast financial expenditures vs. budget, detailed tracking of study status and related invoices.

The position contributes to development and commercialization decisions regarding Teva products by providing expertise in the conduct of clinical trials. This expertise may include serving as a financial liaison for Medical Affairs late phase studies as well as participating as an active member of the Global Medical Teams. The Director will represent the group by participating on various Medical Teams. The Director is responsible for regular interactions with internal and external stakeholders to ensure the successful coordination of Phase IV and ISS programs.
Job Requirements:•7+ years working experience in pharmaceutical or healthcare industries, preferably with patient/consumer initiatives.
•Bachelor’s degree in health science/nursing, or related field
•Experience Required: Minimum 5 years of related pharmaceutical or CRO experience (medical affairs and/or clinical research)
•Experience Preferred: 7 years or more
•Specialized or Technical Knowledge Licenses, Certifications needed: Demonstrated experience in executing and managing clinical trials and/or Investigator Sponsored Studies in the biotechnology and/or pharmaceutical industry
•Functional Knowledge: Strong clinical project/operations skills, clinical and/or medical affairs development experience required.
•Ability to build relationships across a global organization, work independently, build trust and to work efficiently with internal and external stakeholders.
•Company/Industry Related Knowledge: Must have knowledge of GCPs and ICH guidelines.
•Must have knowledge of regulatory guidance concerning ISS programs and Clinical Research.
•Education Required: MBA or relevant MS degree; Relevant certifications such as Six Sigma, CPSM, PMI, Agile, etc.
•Travel Requirements: Domestic or International up to 15%.
Required Experience:7 שנים ומעלה
Locations:מרכז, שרון
Sub Categories:מחקרים קליניים, ביורפואה
Job Scopes:משרה מלאה
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