About Caroline
- Commercial Contracts & Verhandlungen (inkl. Distributoren, Großhandel, Krankenkassen und internationale Partner)
- Regulatory & Compliance (Pharma / MedTech) inkl. Pricing & Reimbursement
- Wettbewerbsrecht & Heilmittelwerberecht
- Datenschutz / Privacy (GDPR)
- Litigation & External Counsel Management (cross-border)
- Interim Legal Support (Überbrückung von Kapazitätsengpässen und Projektspitzen)
- Strukturierung von Legal Demand & Entscheidungsprozessen
- Aufbau von Governance-Strukturen und Risikorahmen
- Entwicklung von Playbooks und Triage-Modellen
- Reduktion von Backlogs und unnötiger Legal-Last
German
Native or bilingual
English
Fluent
Spanish
Conversational
French
Basic
Experience
- FreelanceSenior Legal Counsel | Pharma & MedTech | Decision-Making & Legal Processes (AI-enabled)PHARMACEUTICALS INDUSTRYJanuary 2025 - Today (1 year and 6 months)Frankfurt am Main, Germany
- Providing legal and regulatory advice to an AI-focused pharmaceutical start-up
- Structuring legal demand, decision-making and prioritisation to reduce bottlenecks and improve legal efficacy
- Supporting additional clients via a UK-based intermediary and direct engagements
- Supporting AI-enabled legal workflows to improve scalability and turnaround times
- Dexcom Deutschland GmbH,Director, Legal Counsel EMEAPHARMACEUTICALS INDUSTRYSeptember 2022 - December 2024 (2 years and 3 months)55 Mainz, Germany
- Head of EMEA legal department and member of EMEA leadership team, supporting business expansion across 40+ markets
- Led complex commercial contracts (incl. distributors, wholesalers, health insurance) in highly regulated environment
- Advised senior leadership on key commercial and regulatory matters across multiple jurisdictions
- Managed cross-border disputes and external counsel across EMEA
- Significantly improved efficiency by standardising legal processes (e.g. approvals, contract management) and eliminating backlogs (450+ contracts, 300+ marketing materials)
- Lilly Deutschland GmbH,Senior Legal CounselPHARMACEUTICALS INDUSTRYOctober 2010 - June 2022 (11 years and 8 months)61 Bad Homburg, Germany
- Advised BioMed, Oncology and Diabetes BU across DACH and Europe in a highly regulated environment
- Supported complex commercial agreements (incl. co-marketing, co-promotion and alliances)
- Advised on marketing, digital health solutions and patient engagement initiatives
- Managed cross-border litigation and external counsel, including governance structures
- Conducted internal investigations and supported audits
- Improved legal efficiency and consistency by implementing contract, approval and repository processes
- Led international team and accelerated delivery of legal support
- Member of Austrian and Swiss leadership team (former member Germany)
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Education
- Admission to the BarAssociationAdmission to the Bar
- Second State law ExaminationHigher Regional Court2006Second State law Examination