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Marta Vassallo

@martavassallo

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I translate complex clinical data into compliant regulatory and medical documentation.

Italy

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At Evidilya, I author and review study protocols, CSRs, IBs, CEPs/CERs, ICFs, research papers, and submission dossiers for medical devices, pharmaceuticals, and food supplements.

I manage more than 10 concurrent projects and coordinate directly with clients and project managers to deliver study-related documentation in line with EU MDR 2017/745 and ICH-GCP.

Before becoming Senior Regulatory & Medical Writer, I progressed through Study Start-Up & Regulatory Lead, Specialist, and Clinical Trial Assistant roles at Evidilya. I led ethics committee and regulatory submissions, site-selection support, and timelines across approximately a dozen clinical studies.

My clinical research background includes co-founding a post-stroke rehabilitation research lab at ICS Maugeri and authoring protocols, informed consent forms, and scientific manuscripts. I hold a PhD in Clinical, Experimental Medicine & Medical Humanities and have contributed to 10+ peer-reviewed publications and conference papers.

Experience

Work history, roles, and key accomplishments

Current

Senior Regulatory & Medical Writer

Current

Evidilya

Apr 2026 - Present (5 months)

Authors and reviews clinical and regulatory documentation including study protocols, CSRs, IBs, CEPs/CERs, ICFs, and submission dossiers for medical devices, pharmaceuticals, and food supplements in compliance with EU MDR 2017/745 and ICH-GCP. Manages 10+ concurrent projects and liaises directly with clients on medical writing deliverables.

Regulatory Writing Medical Writing Protocols CSR IBS CEPs CERs ICFs MDR 2017 745 ICH GCP Project Management Client Liaison

Study Start-Up & Regulatory Lead

Evidilya

Jan 2024 - Mar 2026 (2 years 2 months)

Progressively promoted across three roles within 18 months. Led study start-up activities including ethics committee and regulatory submissions, site selection support, and timeline management across approximately a dozen clinical studies. Authored and reviewed clinical and regulatory documentation supporting ongoing trials.

Study Start Up Regulatory Submissions Committee Liaison Site Selection Timeline management Clinical Documentation Protocols CSR CEPs CERs

Researcher & PhD Candidate

University of Insubria

Jan 2021 - Dec 2025 (4 years 11 months)

Designed and managed research projects, including study start-up support and budget coordination. Organized scientific seminars and taught at graduate and post-graduate levels.

Research Project Management Study Start Up Budget coordination Seminar Organization Teaching Graduate Education Postgraduate Education

Research Coordinator and Researcher

ICS Maugeri

Jan 2022 - Dec 2024 (2 years 11 months)

Co-founded a clinical research lab studying rehabilitation outcomes in post-stroke patients. Authored study protocols, informed consent forms, and scientific manuscripts, and analyzed clinical data collected from patient cohorts.

Clinical Research Protocols Informed Consent Forms Manuscripts Data Analysis Rehabilitation Post Stroke