Stéphanie Demoulin
Medical Writer at Bioxodes- Claim this Profile
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English Professional working proficiency
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French Native or bilingual proficiency
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Deutch Elementary proficiency
Topline Score
Bio
Credentials
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Regulatory Writing Overview: Roles, Documents and Process
American Medical Writers Association (AMWA)Dec, 2022- Sep, 2024 -
Creating a Highly Effective Road Map for Clinical Research: Authoring the Clinical Study Protocol
American Medical Writers Association (AMWA)Jun, 2022- Sep, 2024 -
Informed Consent: Comprehensive Concepts and Components
DIAJun, 2022- Sep, 2024 -
Designing Clinical Research Protocols Training Certificate
European Centre for Clinical Research Training (ECCRT)Mar, 2022- Sep, 2024 -
Writing in the Sciences
Stanford OnlineAug, 2021- Sep, 2024 -
Design and Interpretation of Clinical Trials
The Johns Hopkins UniversityJun, 2021- Sep, 2024 -
Photoshop CS6 - initiation + perfectionnement
IFAPMEDec, 2015- Sep, 2024 -
CRA training (6 days training at Cefochim)
BioWinApr, 2015- Sep, 2024 -
Clinical trial : developing a protocol (1 day training at Cefochim)
BioWinApr, 2015- Sep, 2024 -
Data management (3 days training at Cefochim)
BioWinApr, 2015- Sep, 2024 -
Regulatory affairs & regulatory intelligence (2 days training)
BioWinMar, 2015- Sep, 2024 -
FELASA Certificate - Category C
Université de Liège (ULg)Jan, 2011- Sep, 2024 -
Refresher ICH GCP E6 (R2) Training
AML Clinical Services bvbaNov, 2022- Sep, 2024 -
Refresher ICH GCP E6 (R2) Training
AML Clinical Services bvbaNov, 2021- Sep, 2024 -
Good Clinical Practices
CefochimOct, 2019- Sep, 2024 -
ICH GCP Training Certificate
TransCelerate BioPharma Inc.Dec, 2016- Sep, 2024 -
Good Clinical Practices
BioWinApr, 2015- Sep, 2024
Experience
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Bioxodes
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Belgium
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Biotechnology
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1 - 100 Employee
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Medical Writer
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Sep 2021 - Present
Responsibilities- Gather, review, analyze, and evaluate pertinent resources to prepare, develop, andfinalize clinical documents, including but not limited to: briefing documents, IB, study protocols, ICF, interim and final clinical study reports and safety update reports.- Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.- Participate in the redaction and/or reviewing of clinical, regulatory and other documents for submission to Competent Authorities and Ethics committee.- Support the preparation of Health Authority meeting-related documents.- Maintain and demonstrate comprehensive knowledge of applicable regulatory guidelines.- Write clinical summaries and clinical overviews.- Perform quality control (QC) review of clinical documentation and other written submissions.- Coordinate the document preparation, review, and approval process.- Author and/or revise non-clinical protocols and reports.- Discuss and review intellectual property (IP) documents.- Write non-clinical and clinical publications, abstracts, presentations and design of posters.
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Scientific Writer
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Dec 2016 - Sep 2021
Nonclinical:- Participation in study design and protocol development- Review/analysis of data & redaction of scientific reports / publicationsClinical/regulatory:- Redaction/review of regulatory documents (briefing doc, IB, DSUR...) - Redaction/review of clinical documents (protocol, synopsis, ICF, CRF, study report...) & review/analysis of clinical data- Participation in Trial Master File document storageQuality:- Redaction/review of internal SOPsIP:- Management of the IP budget & portfolio in collaboration with European Patent Attorneys Communication:- Maintenance of the company website / Twitter / Linkedin webpages- Preparation of company supports for internal & external presentationsMain topics: Thrombosis, Hemostasis, Anticoagulation, Coagulation pathways, Preclinical and Phase I clinical studies, FXI/FXII inhibitors, Animal models (bleeding, extracorporeal circulation, cardiopulmonary bypass, ...).
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University of Liège
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Belgium
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Higher Education
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700 & Above Employee
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Postdoctoral scientific collaborator
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Oct 2014 - Nov 2016
Development of a therapeutic approach aiming to hamper tumor promotion of breast cancers resistant to standard therapy thanks to mouse models. Main topics: HMGB1, tumor microenvironment, breast cancer, cancer (immuno)therapies, immune cells.- 8 colors flow cytometry- experiments on mice- mammalian cell cultures - identification of specific inhibitors- qPCR, ELISA, ...Collaboration with N. Bendriss-Vermare (Centre L. Berard, Lyon).
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PhD Student
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Jan 2010 - Sep 2014
Implication of dendritic cells (conventional and plasmacytoid) in cervical cancer progressionMain topics : cervical cancer, HPV, immunotherapies, tumor microenvironment, immune cellsTechniques acquired:q(RT)PCR, western blot, ELISA, DNA/RNA extraction, immunohistochemistry, multicolor flow cytometry, mixed lymphocyte reaction assay, WST-1 assay, Alamar blue assay,...Expertise in mammalian cell culture (cancer cell lines) and immune cells generation from primary cells (buffy coats or cord blood).Scientific communication:Writing of projects, reports, articles with peer-reviewing, abstracts, application for Animal Ethics Committees, poster/oral communications in national and international congress.
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Education
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2010 - 2014
Université de Liège
PhD in Biomedical and Pharmaceutical Sciences, Functional alterations of dendritic cells during cervical cancer progression -
2007 - 2009
Université de Liège
Master's Degree, Biomedical sciences - Immunology and cancer -
2004 - 2007
Université de Liège
Bachelor's Degree, Biomedical Sciences, General -
2004 -
Athénée Royal de Huy
Certificat d'enseignement secondaire - enseignement de formation générale
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