プロフィール詳細

プロジェクトを作成

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Sofia B.に依頼

Portugal

Medical and regulatory writer with 7 years of experience in clinical research

プロフィール概要

I have extensive experience in non-clinical and clinical research, with strong collaboration with pharmaceutical industry clients. I designed and executed clinical studies, including observational and Phase 1/2 trials, contributing to advancements in multiple therapeutic areas. My skills involve developing regulatory documents, study protocols, clinical trial reports, manuscripts, educational materials, and data analysis. I feel comfortable in international teams working across large projects and I developed strong relationships with clients. I look forward to leveraging my critical thinking to achieve an impact on clinical research and regulatory compliance.

専門分野

• ☆ Neuroscience
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Trials
• ☆ Clinical Trial Design
• ☆ Regulatory Writing
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Technical & Scientific Writing
• ☆ SOP & Protocol Writing
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review

サービス

• Writing

Writing Clinical Trial Documentation, Medical Writing

職務経験

Grant and Protocol Specialist

Keyrus Lifesciences

8月 2022 - 10月 2024

Functional Analyst

NTT Data

11月 2020 - 7月 2022

Scientific Affairs Manager

Pharmaissues

8月 2017 - 9月 2019

Postdoc position

Université Paris Descartes

12月 2014 - 11月 2016

Researcher

Institut du Cerveau

4月 2014 - 11月 2014

PhD fellowship

Foundation for Science and Technology (FCT)

4月 2010 - 3月 2014

Research fellowship

Centre for Neuroscience and Cell Biology

2月 2008 - 1月 2010

学歴

PhD (Faculty of Medicine)

University of Coimbra

3月 2010 - 4月 2014

Master (Faculty of Science and Technology)

University of Coimbra

9月 2007 - 7月 2009

BSc (Faculty os Science and Technology)

University of Coimbra

9月 2000 - 9月 2005

認定資格

• Foundational ICH-Good Clinical Practice (GCP) E6

  European Centre for Clinical Research Training (ECCRT)

  1月 2024 - 現在

出版物

JOURNAL ARTICLE

Sofia Baptista, Joana Lourenço, Nuno Milhazes, Fernanda Borges, Ana Paula Silva, Alberto Bacci(2016). Long-Term Treatment with Low Doses of Methamphetamine Promotes Neuronal Differentiation and Strengthens Long-Term Potentiation of Glutamatergic Synapses onto Dentate Granule Neurons . eneuro. 3. (3). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString ENEURO.0141--16.2016. Society for Neuroscience