Senior Consultant Clinical Affairs – Medical Writer
Diana is part of the German Qserve Team. Her area of expertise is clinical affairs. Diana is a biologist who has been working in the pharmaceutical/med-tech field for over 15 years. She is a medical writer certified in medical communications and regulatory writing by the European Medical Writers Association.
The key areas of expertise of Diana are:
- Development of clinical strategies for the EU
- Planning and design of clinical studies, including the selection of (surrogate) endpoints, biomarkers, clinical rating scales and validated questionnaires
- Clinical support of R&D, RA, QA and marketing activities
- Implementation of product development from bench to market
- Internal and external clinical process improvement
- Hands-on experience in writing investigators’ brochures, clinical investigation plans, informed consent forms, case report forms and clinical study reports
- Preparation of post-market clinical follow-up (PMCF) plans and reports as well as periodic safety update reports (PSURs)
- Preparation of clinical evaluation plans (CEPs) and clinical evaluation reports (CERs) according to MEDDEV 2.7/1 Revision 4
Diana about working at Qserve
“Qserve is a hub of expertise in the field of medical devices. I am impressed by the knowledge and experience of my colleagues in the various areas (clinical, regulatory affairs and quality management). Qserve translates compliance with regulations into a practical approach, always guided by the best business interest of clients. Most striking is Qserve’s culture of sharing knowledge, both internally between the teams and externally with clients (for instances by providing customized trainings or webinars). Altogether, this makes Qserve unique in its field.”
Diana holds a M.Sc. in Biology, a Ph.D. in Microbiology and diplomas in Business Administration, Marketing and Sales. After her Ph.D., Diana started her career as a freelance medical writer by writing and translating regulatory documents for registration of medicines in the EU. These services were later expanded to medical devices. She then moved into the field of medical communications, specializing in the preparation of scientific documents (e.g. manuscripts for peer-reviewed journals), educational materials (e.g. e-learning), and marketing and PR materials (both online and print).
She led the global publication team of a company whose portfolio included drugs, class III medical devices and cosmeceuticals. In her last position as global science manager in the industry, she focused on the preparation of clinical evaluation reports as well as support for the conduct and report of clinical studies of implantable class IIb medical devices.
Diana has worked with some of the top 10 pharmaceutical companies, global manufacturers of medical devices, leading translation and communication agencies worldwide, as well as renowned research institutes and universities in Europe. Her main subject areas are aesthetic medicine, cardiovascular diseases, dietetics, endocrinology, infectious diseases, neurology/psychiatry, oncology and ophthalmology. Diana speaks fluently English, German, Portuguese and Spanish.