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    Clinical Scientific Program Lead (m/w/d)

    Location: Wedel, from: 14.07.2020
    You are an innovative person with a passion for details and team spirit? We are looking for graduates for the scientific and pharmaceutical sector. We can offer you new challenges, regular continuing education courses, internal mobility and attractive benefits in a company that thinks of the future and acts accordingly. With passion, team spirit and appreciation for one another.
    • Preparation of the medical scientific content of global and country-specific regulatory documents for new compounds as well as lifecycle activities for medac’s product portfolio (e.g. CCDS, PSURs, DSURs, IB, IMPD, PIP, Clinical Expert Statements, Risk Management Plans, Clinical Overview; Clinical Summary, Package leaflets)
    • Supports the evaluation of potential clinical development projects for new product opportunities
    • Acting as global clinical program lead, overseeing multiple trials in a clinical development and leads the clinical program team being accountable for excellence in clinical trial strategy and leadership for design, execution and reporting ensuring high quality data
    • Undertakes product and therapeutic area reviews
    • Provides evidence-based medical and scientific input to regulatory, strategy and trial-related documents
    • Supports other departments like Marketing, Market Access, Regulatory Affairs, Pharmaceutical Development, Non-Clinical Development, Clinical Research with medical-scientific input there were necessary
    • Build relationship among medical/scientific community and with external experts
    • Medical Doctor or PhD in Lifescience
    • 5 years + clinical development experience within the Pharmaceutical Industry, preferably in the indications oncology, haematology and autoimmune diseases
    • Experience in strategic planning, designing and executing Clinical Development Programs
    • Hands on mentality with good organisational and project management skills
    • Demonstrated track record in regulatory writing of relevant documents
    • Team player with strong communication skills
    • Fluency in English and at least basic skills in German
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