Acerca de Elena
I am a PhD-trained biomedical scientist and professional medical writer supporting pharmaceutical and medtech companies with clear, structured, and scientifically rigorous documentation.
I specialize in:
- Medical and clinical documentation
- Regulatory writing for medical devices and pharma products (EU MDR and legacy MDD frameworks, safety and performance documentation)
- Clinical evaluation plans (CEP) and clinical evaluation reports (CER)
- Scientific Advisory Board meeting minutes (accurate, structured, and actionable)
- Scientific manuscripts for publications in peer-reviewd journals
With over 15 years of research experience and extensive expertise in clinical oncology, molecular and cellular biology, neuroscience, and biomedical imaging, I bring both scientific depth and regulatory precision to every project.
For medtech projects, I have:
- Produced Clinical Evaluation Plans and Clinical Evaluation Reports for medical devices
- Assessed compliance with MEDDEV 2.7.1 Rev. 4, MDD, and MDR 2017/745
- Conducted structured literature appraisals to support state-of-the-art and clinical evaluation sections
- Verified accuracy and consistency of technical documentation
I work with medical affairs teams, regulatory departments, and research groups who require precision, reliability, and discretion.
For Advisory Board meetings, I deliver comprehensive and structured minutes that accurately capture key scientific discussions, strategic insights, and clinical considerations — ensuring clarity for internal stakeholders and compliance documentation.
If you are looking for a medical writer with solid academic background who understands both the science and the regulatory landscape, I would be pleased to discuss your project.
Inglés
Bilingüe o nativo
Ruso
Bilingüe o nativo
Francés
Competencia profesional básica
Alemán
Competencia profesional básica
Hebreo
Competencia profesional completa
Acepta trabajo presencial
Gif-sur-Yvette (hasta 50 km), Paris (hasta 100 km)
Experiencia
- ISS AGMedical WriterBIOTECNOLOGÍAfebrero de 2022 - Hoy (4 años y 4 meses)Geneva, Suiza• Produced clinical evaluation reports on medical devices• Checked compliance with regulations according to MEDDEV 2.7.1 Revision 4, MDD and MDR 2017/745• Appraised literature to support state of the art and clinical evaluation sections• Verified accuracy of technical documentation on medical devices
- Cactus CommunicationsScience EditorCENTROS DE INVESTIGACIÓNdiciembre de 2019 - Hoy (6 años y 6 meses)Write and edit science manuscripts in biomedical fields. Prepare manuscripts for publication in peer-reviewed science journals, check the language for grammar, readability and flow, verify the references for accuracy and consistency, write the missing text, ensure consistency in terminology, reduce word count when necessary.
- CNRSStaff scientistCENTROS DE INVESTIGACIÓNjulio de 2017 - diciembre de 2019 (2 años y 6 meses)Gif-sur-Yvette, FranciaConducted scientific studies of embryo development.
Reseñas
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Formación
- PhD in Molecular BiologyGöttingen University2008