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    Team Lead - Oklahoma City, United States - FUTRUE

    FUTRUE
    FUTRUE Oklahoma City, United States

    3 weeks ago

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    Description

    Über uns

    FUTRUE ist mehr als ein international ausgerichteter Healthcare-Konzern Mit mittlerweile über 20 Unternehmen und mehr als 70 Arzneimittelzulassungen sind wir u.a. in den Bereichen intelligente Bakterien, innovative Schmerztherapien sowie chemiefreie Arzneimittel weltweit führend. Zahlreiche unserer Unternehmen, darunter z.B. SYNformulas oder Vertanical, gehören zu den am schnellsten wachsenden Healthcare-Unternehmen. Um diesen Erfolg fortzuführen, setzen wir auf eine neue Generation dynamischer Talente, die den Mut haben, ungewohnte Wege zu gehen.

    Aufgrund unseres dynamischen Wachstums sowie der kontinuierlichen Erweiterung unseres Produktportfolios suchen wir nach motivierten und engagierten Talenten für unsere erfolgreichen Teams. Unser Ziel ist es, so vielen Menschen wie möglich ein besseres Leben zu schenken.

    Willst Du die Zukunft mitgestalten? Dann bewirb Dich jetzt
    Deine Aufgaben

    Du bist verantwortlich für die Qualität unserer Arzneimittelstudien – dabei stellst Du die Einhaltung von GCP Vorgaben und angrenzender Regularien bei uns, unseren Vendoren und unseren Prüfzentren sicher.
    Du leitest unser Clinical Quality Assurance Team fachlich und disziplinarisch.
    Du qualifizierst, überwachst und bewertest unsere Vendoren im Umfeld klinischer Studien.
    Du entwickelst und implementierst Oversight Strategien, um mögliche Compliance Issues frühzeitig auszuräumen – bei uns, unseren Vendoren und Prüfzentren.
    Du bewertest Findings von Monitoring CROs, Auditoren und Inspektoren bei Vendoren und Prüfzentren und leitest ggf. Maßnahmen ein.
    Du verantwortest den TMF mitsamt Planung, Strukturierung, Pflege, Qualitätssicherung und Archivierung.
    Du unterstützt bei der Vorbereitung von Behördeninspektionen.
    Dein Profil

    Du hat ein abgeschlossenes BS/BA- oder MS/MA-Studium in Medizin, Naturwissenschaften, Pharmazie, Biotechnologie oder vergleichbar.
    Du hast mindestens 5 Jahre Erfahrung in der klinischen Forschung, davon idealerweise 3 Jahre in der Qualitätssicherung.
    Du bringst ein umfassendes Verständnis der regulatorischen Vorgaben einschließlich ICG GCP E6, VO 536/2014, RL 2001/20/EC, AMWHV und AMG mit.
    Du hast Erfahrung in der Erstellung von SOPs, studienspezifischen Plänen und WIs.
    Du hast Erfahrung im Umgang mit Behörden, Vendoren und Prüfärzten und keine Scheu, Deinen Bereich vor senioren Ansprechpartnern zu vertreten.
    Du bist neugierig, offen für Neues und hast Freude daran, komplexe Probleme zu lösen.
    Du arbeitest eigenmotiviert, strukturiert, präzise und lösungsorientiert; von neuen Themenbereichen lässt Du Dich nicht einschüchtern.
    Du bringst verhandlungssichere Deutschkenntnisse (mind. C1-Level) und sehr gute Englischkenntnisse (mind. B2-Level) mit.
    Unser Versprechen

    Wir setzen Dinge um – und das schnell Dich erwartet ein Top-Management-Board von hochklassigen Unternehmern, früheren Beratern und erfahrenen Industrie-Größen. Wir bieten Dir das Umfeld, in dem Du Dich persönlich und beruflich beispiellos weiterentwickeln kannst.
    Dein direkter Kontakt zu unserer HR Abteilung

    Bewirb Dich jetzt Wir freuen uns darauf, Dich kennenzulernen.

    Du hast Rückfragen?
    Wende Dich gerne direkt an Deinen zuständigen Ansprechpartner:

    FUTRUE GmbH
    Sarah Glöckler
    Am Haag 14
    82166 Gräfelfing

    #J-18808-Ljbffr


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