À propos 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.
Anglais
Bilingue ou natif
Russe
Bilingue ou natif
Français
Capacité professionnelle limitée
Allemand
Capacité professionnelle limitée
Hébreu
Capacité professionnelle complète
Accepte de travailler sur site
Gif-sur-Yvette (jusqu’à 50 km), Paris (jusqu’à 100 km)
Expériences
- ISS AGMedical WriterBIOTECHNOLOGIESfévrier 2022 - Aujourd'hui (4 ans et 4 mois)Geneva, Suisse• 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 EditorCENTRES DE RECHERCHEdécembre 2019 - Aujourd'hui (6 ans et 6 mois)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 scientistCENTRES DE RECHERCHEjuillet 2017 - décembre 2019 (2 ans et 6 mois)Gif-sur-Yvette, FranceConducted scientific studies of embryo development.
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Formations
- PhD in Molecular BiologyGöttingen University2008