Profile Details

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Hire Sofia B.

Portugal

USD 30 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ☆ 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

Services

• Writing

Writing Clinical Trial Documentation, Medical Writing

Work Experience

Grant and Protocol Specialist

Keyrus Lifesciences

August 2022 - October 2024

Functional Analyst

NTT Data

November 2020 - July 2022

Scientific Affairs Manager

Pharmaissues

August 2017 - September 2019

Postdoc position

Université Paris Descartes

December 2014 - November 2016

Researcher

Institut du Cerveau

April 2014 - November 2014

PhD fellowship

Foundation for Science and Technology (FCT)

April 2010 - March 2014

Research fellowship

Centre for Neuroscience and Cell Biology

February 2008 - January 2010

Education

PhD (Faculty of Medicine)

University of Coimbra

March 2010 - April 2014

Master (Faculty of Science and Technology)

University of Coimbra

September 2007 - July 2009

BSc (Faculty os Science and Technology)

University of Coimbra

September 2000 - September 2005

Certifications

• Foundational ICH-Good Clinical Practice (GCP) E6

  European Centre for Clinical Research Training (ECCRT)

  January 2024 - Present

Publications

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). p. ENEURO.0141--16.2016. Society for Neuroscience