I currently provide specialized consulting services through AP Healthcare Communication & Transparency Solutions GmbH for Interconnected Expertise across medical writing, clinical trial transparency and patient-centred scientific communication, ensuring continuity across document development, regulatory requirements and downstream public disclosure.
At Alexion Pharmaceuticals (AstraZeneca rare disease unit), I co-established its first integrated Health Literacy, Patient-centred communication and Clinical Trial Transparency function for global rare disease programmes. I designed a patient engagement communication framework and scaled delivery of 50+ lay summaries, protocol synopses, and study information.
I integrate transparency-by-design into scientific communication, enabling responsible public disclosure while protecting personal data and commercially confidential information. My work has supported compliant disclosure under EU CTR, EMA Policy 70, Health Canada PRCI, and UK HRA through risk-based anonymisation and redaction.
My regulatory medical writing experience provides the scientific foundation underpinning my communication work. Over 17 years, I have supported successful global regulatory approvals through multi-indication submissions (NDA, BLA, MAA), product lifecycle management, scientific publications, and developed novel paediatric extrapolation reports and specialised safety summaries across pharmaceutical companies.
I drove alignment on communication standards and supported global adoption of governance frameworks, systems, tools, and processes.
