Independent strategic healthcare consulting and operational support of medical projects in the biopharmaceutical industryServices: - Management Consulting - Medical Advisory, Medical Monitoring & Clinical Development/Operations - Interim Management - Regulatory Medical WritingReferences:Management Consulting:- Associated Director at a boutique life sciences management consulting firm- Principal at a strategy consulting firm for the life sciences industryMedical Advisory:- Medical Monitor of global phase 3 studies in orphan diseases- Medical Scientific Liaison Management for global orphan drug company- Design of global phase 3 studies in orphan diseasesInterim Management:- Medical Monitoring of global phase 3 studies in orphan diseases including pharmacovigilance activities, and conduct of Data Safety Monitoring Board Meetings- Medical Advisory during regulatory defence processes in centralized MAA (EMA) and NDA (U.S. FDA) of orphan medicinal products including preparation of corresponding response documents and participation in meetings with regulatory authorities- Medical Advisory in preparing dossiers for HTA Bodies (G-BA) and participation in corresponding Oral Hearings- Cross-functional biosimilars brand management in a global biotechnology company including development and implementation of target-group specific multi-stakeholder, multi-channel awareness campaign (COMPRIX Gold Awards & Finalists), commercial stakeholder engagement strategies, and cross-functional preparation of a biosimilars product launch- Project Manager developing and implementing a biosimilars product strategy- Project Manager preparing a communication strategy and product launch Regulatory Medical Writing:- Clinical Summaries for EMA & FDA Briefing Books- CTD Clinical Overviews & Summaries- Clinical Study Protocols, Clinical Study Reports PIP, IB, SMP, DSUR/PSUR etc.

Representative Managing Director: - Customer liaison and support - Personnel management - Business controlling - Business development and acquisitionMedical Consulting: - Scientific marketing concepts and strategies - Medical and strategic product positioning - Training presentations - Intra-corporate publications - Direct marketing

Healthcare ConsultingBiotech company listed on the German stock exchange: - Analysis of processes and organization, reorganization and rationalization - Concept of a new marketing- and sales-organizationGerman market leader in health insurances: - Development and implementation of disease management programs - Development of a national marketing- and communication-strategy

Clinical Operations: - Strategic planning, coordination and budgeting of clinical studies in Germany, Europe and USAScientific Marketing: - Public relations with key opinion leaders - Scientific papers and informational material - Preparation of German and European product launch Pharmacovigilance Management

Clinical Function: - Pediatrics, neonatology, (ward, out-patient and on-call duty)Research: - “Cord blood association”: Project planning and implementation, public relations, data analysis for research purposes Teachings: - Diverse projects to represent the Department of Neonatology: “Living Medicine” (07/98), “Research Days” (08/98) of the Humboldt-University, Berlin