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CORALIE Coralie Gamper

CV Gamper Coralie

Summary

I’m a regulatory medical writer with a background in neuroscience and oncology, and a strong interest in drug development and regulatory strategy. I specialize in authoring clinical and regulatory documents that support the development and approval of new therapies (CTD modules, IBs, CSRs, CSPs, ICFs, Summary for Laypersons).
Currently expanding my expertise toward regulatory affairs certification (RAC Drugs).

Professional experiences

Medical writer

Azur Health Science

Since 2. december 2023

- Clinical Trial Reports - Clinical Trial Protocols - Synoptic Clinical Trial Report - Investigator's Brochure - Informed Consent Forms - Pediatric Investigational Plan waiver - Safety narratives - Briefing Documents - Summary for Laypersons for the UK Health Regulatory Authority - Systematic Literature Reviews - Research articles

Associate medical writer

Azur Health Science

From September 2022 to December 2023

- Clinical Trial Reports - Clinical Trial Protocols - Synoptic Clinical Trial Report - Investigator's Brochure - Pediatric Investigational Plan waiver - Patient narratives - Research articles - Congress coverage

Project manager

Lund University

From July 2020 to January 2022

• Scientific literature reviewing • Ethical permit writing • Data analysis • Problem solving • Time management • Written and oral communication

Researcher phd candidate

CNRS - Centre national de la recherche scientifique

From November 2015 to September 2019

With support by a PhD fellowship from the Ligue contre le Cancer the candidate I joined an interdisciplinary project combining expertise from plant virology (M. Heinlein, IBMP-CNRS, Strasbourg) and cancer medicine (D. Bagnard, member of team of G. Orend, INSERM U 1109, Strasbourg) to develop plant virus-derived nanoparticles as a platform for the expression and delivery of anti-cancer drugs.

Project engineer

INSERM

From September 2015 to October 2015

Project engineer

INSERM

From June 2014 to May 2015

Additional training

Doctorat

Univesité de Strasbourg - Biotechnologie

2015 à 2019

Degree

Master Vie et sante - Neurosciences : joint master in neuroscience – MASTER LMD – Faculté des sciences de la vie – 2012
Licence Sciences du vivant - biochimie et biologie moleculaire – LICENCE LMD – Faculté des sciences de la vie – 2012
Licence Sciences du vivant - biochimie et biologie moleculaire – LICENCE LMD – Faculté des sciences de la vie – 2011

Languages

Anglais - Courant

Français - Langue maternelle

Suédois - Technique

Skills

Preclinical models of cancer
Cellular biology

Hobbies

  • Travelling
  • reading
  • obstacle races.