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Skills
Medical Writing
Creation, revision, translation, and editing of promotional and non-promotional materials (HCP and patient). Preparation of reports and manuscripts covering medical advisory board meetings for various medical fields.
Scientific Writing
Extensive experience in writing peer-reviewed manuscripts, reviews, abstracts, and posters.
Regulatory Affairs
Creation, review, and update of regulatory documents ensuring compliance with ISO 13485:2016 and Medical Device Directive. Implementation of regulatory requirements in collaboration with R&D and Production.
Cancer Biology Research
Conducted independent research on Cancer biology in an industrial environment, resulting in peer-reviewed articles. Strong analytical and organizational skills demonstrated by analyzing large scientific datasets.
Project Management
Ability to meet tight deadlines and manage multiple projects simultaneously. Collaboration with team members to design and implement multiple projects.
Software Proficiency
Proficient in MS Office, GraphPad Prism 9.2, JMP 16, Flow Jo Ver 10.8, Zotero, and EndNote for data analysis and document preparation.
Clinical Trial Knowledge
Certifications in Good Clinical Practice, EU Drug Development Process, Clinical Study Reports, and Regulatory Medical Writing Basics.
Projekthistorie
04/2024
-
bis jetzt
Medical and Scientific Writer
Freelance
Preparation of reports and manuscripts for medical communication agencies, covering various medical fields. Creation and editing of promotional and non-promotional materials.
12/2023
-
05/2024
QM Associate – Regulatory affairs
Dr. Langer Medical
Creation, review, and update of regulatory documents ensuring compliance with ISO 13485:2016 and Medical Device Directive. Participation in regulatory audits and implementation of regulatory requirements.
02/2020
-
01/2024
Marie Skłodowska-Curie PhD fellow
Charles River Laboratories
Conducted independent research on Cancer biology, resulting in peer-reviewed articles. Demonstrated strong analytical and organizational skills in analyzing large scientific datasets.
10/2021
-
12/2021
Visiting PhD researcher
Medical University of Vienna
Demonstrated high-level organisational skills in accomplishing set goals in a limited time frame.
07/2019
-
02/2020
Associate researcher
RBM Merck S.p.A., Colleretto Giacosa (Turin)
Troubleshooting and problem-solving in the development and validation of new cell-based bioassays. Collaborated with team members to design and implement multiple projects.
09/2018
-
03/2019
Research Intern
APHAD S.r.l and Mario Negri Institute of Research, Milan area
Participated in the 'Drug Design and Development' program. Mediated collaboration between academic and industrial sectors. Developed immunoassays for validating protein biomarkers of Amyotrophic Lateral Sclerosis.
Zertifikate
“Good Clinical Practice”
National Drug Abuse Treatment Clinical Trials Network
2024
“A Beginner’s Guide to Key Clinical Documents in the EU Drug Development Process”
EMWA
2024
Clinical Study Reports - Mastering the Essential Skills”
EMWA
2024
“Regulatory Medical Writing Basics”
Udemy
2024
“Design and Interpretation of Clinical Trials”
The Johns Hopkins University
2024
“Sharpen Up Your Writing Skills”
EMWA
2024
“Communicating Research: Paper Writing And Short Presentations”
EMBO
2023
Reisebereitschaft
Weltweit verfügbar
Freelance Medical and Scientific Writer with PhD in Cancer Biology
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