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Medical Affairs Manager - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

  • Województwozagranica
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  • AdresGermany,
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Medical Affairs Manager

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  • Role:Medical Affairs ManagerRate:90 EUR P/HTherapeutic Area:Oncology and FertilityDuration:2 MonthsLocation:Frankfurt (Area)Languages:English (business fluency)Description: * Provide strategic consultancy to Global/Regional/Local Medical Affairs in terms of study proposals and the overall management of clinical studies. * Manage and set up of Decision boards for Data Sharing and Patient Support programs * Support CMO office in daily business in terms of Governance and Compliance * Support Strategic projects in GMA/GDS * Develop and maintain strong, mutually supportive working relationships and collaboration with each of the departments within GMA/GDS as well as key stakeholders within Global R&D * Conceptual design support of study proposals. Providing expert input to GCP; Insurance; Compliance; Regulatory and Legal related aspects of Medical Affairs studies (local studies, Investigator sponsored studies) * Set up and management of decision boards for Data Sharing and Patient Support programs for marketed drugs. * Support the Secretary of the Decision Board of assigned Therapeutic Areas. Ensure cleaning and review process in regards to scientific, conceptual and design maturity of Medical Affairs study proposals * Tracking and Traceability of the status of all Medical Affairs Trials and act pro-actively on any identified issue to support resolution of them * Management, Maintenance and Administration of Medical Affairs owned data systems - Automated Tracking Tool and Proposal/Trial Review and Tracking Management System * Ensure Compliance with GCP and all valid Guidance's and Regulations in regards to Medical Affairs Trials * Implementation and continuous improvement of quality- and compliance-oriented quality documents and processes#LI-GN1


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