Alessandra Zevini
Medical Affairs Specialist
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Info
Medical Affairs Specialist with 5 years of experience in regulatory affairs and clinical research. Proven expertise in preparing and maintaining critical clinical documentation (CEP, CER, SSCP, PMS reports) in full compliance with MDR 2017/745 for Class IIb/III medical devices. Strong background in medical writing, post-market surveillance, clinical investigation management, and cross-functional collaboration with Vigilance and R&D departments.
Ph.D. in Molecular Medicine with specialized training in immuno-oncology provides critical appraisal skills for evaluating complex clinical literature and emerging scientific evidence
Esperienza
Medical Affairs Specialist – Quanta System S.p.A., IT June 2024 - present
- Authored and maintained critical regulatory documentation including CEP, CER, and PMS reports for surgical and aesthetic laser devices in accordance with MDR 2017/745.
- Designed and implemented company-sponsored clinical investigations and managed the full cycle of External Research Program, collaborating with Key Opinion Leaders on protocol development, study start-up and execution, and statistical data analysis.
- Prepared and reviewed high-impact scientific manuscripts for peer-reviewed journals.
- Led the generation and periodic maintenance of critical clinical documentation essential for achieving and sustaining CE certification of class III medical devices (according to MDR 2017/745).
- Managed end-to-end clinical investigation activities: research protocol design, submissions to Ethics Committees and Competent Authorities, site support, and medical writing.
- Established strategic relationships with KOLs in the orthopedic field for clinical evidence generation.
- Liaised with pharmaceutical Sponsors and research sites to accelerate patient recruitment, provide training assistance, and support clinical study operations.
- Performed targeted on-site visits to implement customized recruitment strategies, optimizing enrolment rates and accelerating study timelines.
- Managed start-up activities for multicentre clinical studies, from feasibility assessments to site activation.
- Ensured the collection, reviewand organization of essential documents in electronic Trial Master Files (eTMF), in compliance with ICH-GCP and local regulations.
- Prepared and submitted study protocols and amendments to Ethics Committees.
- Designed and executed complex research projects focused on developing novel anticancer immunotherapies, generating 10 peer-reviewed publications.
- Contributed to the successful writing and submission of research grant proposals.
- Supervised and mentored Master’s and Ph.D. students in their research activities.
- Presented research findings at national and international conferences, as talks and poster presentations.
Generated genetically modified cell lines using CRISPR-Cas9 technology.
Formazione
2nd Level Master in Preclinical and Clinical Drug Development - Technical-scientific, regulatory and ethical aspects La Cattolica University, Rome, Italy. 2021
Ph.D in Biology and Molecular Medicine La Sapienza University of Rome, Italy. 2015
M.S. in Medical Biotechnologies La Sapienza University of Rome, Italy. 2011 Summa cum Laude.
B.S. in Biotechnologies,
La Sapienza University of Rome, Italy. 2009 Summa cum Laude
