PILs, PROs, PIMs, SCALES, eCTDs, DFUs, Registration Dossiers for Medicines (SmPCs, packaging texts), Clinical Trial Protocols and Informed Consent Forms, Instructions for Use (IFUs), Case Study Report Forms, Clinical Study Report Forms, Patient Diaries, Preclinical - Phase IV Documentation, Case Report Forms (CRFs), Patient Guides, Patient Questionnaires, Doctor Guides, Investigator Brochures, Synopses, Training Documentation, CMC documentation, Medical Software...

Traduction et relecture de documents tels que rapports d’hôpital, dossiers d'Autorisation de Mise sur le Marché, RCP (SmPC), notices techniques, documents de pharmacovigilance, essais cliniques, questionnaires ...
Correction d'articles scientifiques rédigés par des non-natifs.
Traductrice certifiée par l'Institute of Translation and Interpreting.
Membre de la Société Française des Traducteurs (SFT).
Co-organisatrice du séminaire d'anglais médical à
l'Université de Lyon.

With 15 years expce writing and translating medical documentation, regulatory and medical communication, I am qualified at Masters level in Biology and worked as a BioEngineer for two years. I translate protocols, informed consent, patients diaries, interfaces for patients data consolidation software and marketing authorizations (inc. SmPCs) for the EMA. Most of my work has taken place in the following areas: oncology, psychiatry, and rheumatology. I am also a medical writer & editor.

Clinical trials, research protocols and associated material, summaries of product characteristics (SmPCs), patient information leaflets (PILs) and consent forms, questionnaires, packaging leaflets, marketing tools, press releases, packaging, standard operating procedures (SOPs), quality assurance processes, safety datasheets (MSDS/SDS), etc.

Medical/scientific documentation (scientific articles, lab reports, lab manuals, etc.)
Devices, Pharmaceuticals, Surveys and Clinical Trials, Informed Consent Forms, Clinical Trials Agreements and Letters, Adverse Event Summaries, Medical Device Information, Lab Reports, Tender documents: Drugs and Drug sundries, Category B Clearance for Operational Unit of Nuclear Medicine: requests for clearance or updates to modifications on activities of Nuclear Medicine, etc.

I have been translating medical and pharmaceutical documents for more than 30 years.
I first started working in pharmaceutical laboratories as a member of the team performing clinical studies follow-up, so it was a hand-on experience as well as, apart from translating all the materials, I was working with physicians and CRAs on all the different aspects of the clinical trials and this experience has been very useful when I decided to work as a free-lance translator.

Nonclinical toxicology study reports, pre-clinical safety profiles, fertility and embryo-fetal development study, PK data, PD data, treatment emergent AE’s, treatment related toxicity, safety summary, response summary, ICF/PIS, SUSAR, SAEs reports, CIOMs, investigator brochures, protocols and protocol amendments, case report forms, lab manuals, e-diary instructions, imaging guideline manuals, annual safety reports, initiation visits, medical monitor visits, sponsor audits.

For the past 7 years I have translated pharmaceutical material for agencies in Spain, France and the US that specialize in serving large pharmaceutical companies. This includes product summary sheets, clinical trials documentation and medical journal articles. Many of my translations have appeared in English-language peer-reviewed medical journals.

Translation for the Medical and Surgical Device Industry:

- Operating, maintenance and installation manuals
- Instructions for use
- Software application interfaces and documentation

Translation of Pharmaceutical Related Documents:

- Pharmaceutical research material

Specialization courses:

2018: University of Minnesota
Medical Technology and Evaluation
Pharmaceutical and Medical Device Innovations

2018: University of Toronto
Introduction to Self-Driving Cars

Clinical trial protocols, informed consents, investigator brochures, drug safety reports, patient information leaflets, user manuals for medical equipment, lab reports, informed consents, patient's records, software interfaces for clinical assessments. Full time medical interpreter for 13 years. Completed a medical terminology college course, "Bridging the Gap" medical interpreter training program, and Design and Interpretation of Clinical Trials course authorized by Johns Hopkins University.

Large experience in clinical protocols and medical literature of all kinds.

More than 10 years of experience. O translated project for big companies, such as Pfizer.

I translated several papers and articles for Research in Genetics, Molecular Biology, Biochemistry, brochures, reports for marketing, training materials and manuals for equipments.

My particular expertise lies in the scientific and technical domains, particularly biotechnology and biomedical. I have a Ph.D. in Molecular Pharmacology and decades of experience in biomedical research, which included numerous collaborations with clinicians and the pharma industry. I frequently translate and proofread biomedical research papers, clinical trials, patient records, data safety sheets, etc. I am thorough and will always go the extra mile to provide accurate and elegant documents.

Somehow, having studied Greek and Latin in high school for 6 years led me to develop a deep interest in medical and pharmaceutical translation. I recognize word roots and origins and find it fascinating. For the pharma companies listed above, and also on a regular basis for Biomérieux (France) and RVC Medical (NL) which are not on that list, I have translated numerous clinical trials, product descriptions, usage, side-effects, etc. I have extreme attention to detail.

Mainly worked for translation agencies, expert in pharma patents.

- BA degree in Translation and Terminology;
- Extensive experience in pharmaceutical content translation, covering anything from clinical trials to marketing authorisations, labelling and package leaflets, summaries of product characteristics etc.;
- Proven experience with technical specifications for medical equipment and medical articles;
- Full compliance with EMA QRD templates, EMEA Guidelines and clinical trial databases;
- Working with medical texts on a weekly basis.

Long-term Collaboration
Translation / Proofreading / Revision / Post-Editing:
Clinical Trials (Informed Consent Forms, Clinical Trial Agreements, Package / Label Information Leaflets)
Pharmaceutical Market Research (Product Profiles, Questionnaires, Screeners)
Related website content

Software: Windows/Mac, Microsoft Office, Internet VDSL, SDL Trados Studio 2019 (license owner); XTM, memsource, MemoQ, Wordbee (web license to be provided by the orderer)

Experience
I have been involved in translation/review of:

Clinical Trial documents including Study Protocols, Investigator's Brochures, Informed Consent Documents, Suspected Unexpected Serious Adverse Reactions (SUSAR) Reports.

Medicines: packaging, labelling and patient information leaflets.

Books and manuals on public health.

Medical papers and others publications in scientific journals.

Studies on scientific and health policies.

Press releases

I have a legal and sociological education background, at the university level, after graduating a technical high-school (automotive area), followed by ten years of office work in health & legal area. I have been also trained in legal matters (Civil, Penal and Commercial codes). I have also experience and adequate skills in the localisation of software.
- translation of an about 30 pages medical report (Oncology)
- translation of an about 70 pages medical report (Hearing Deficiency)
others.

I’ve experience in translating documents, trainings, reports, and all sorts of documents such as case report forms, investigational product, research protocol, protocol compliance and protocol deviations, clinical trial documentation and Investigator's Brochure, letter for indemnification, drug safe reports, CIOMS reports, clinical trial agreement, medical equipment user guides, catalogues/sales brochure, software localization, agreements and contracts, etc.

I have 8+ years of experience translating various types of pharmaceutical documents, including summaries of product characteristics (SmPC), informed consent forms for clinical trials on investigational medicinal products, various patient-facing materials (dosing instructions, package leaflets, etc.), I also have extensive experience translating medical journal articles about pharmaceutical products in a post-marketing context. Nearly all of my pharma work has come through LSPs.

Medical and veterinary articles
Clinical trial protocols and informed consent forms for patients
Description of medical and pharmaceutical products
Specialised webpages
Case reports, disease cards
Prevention, diagnosis and treatment guides
Labels, inserts
Presentations for conferences

- MD (junior radiologist) and pharmaceutical/ medical translator since 2007
- Multiple medical/ pharamceutical translation areas covered (scientfic articles, pharmaceutical documents, medical marketing, technical documents, etc.)
- Accurate and reliable
- Certified by The Polish Federation of Engineering Associations (FSNT–NOT)
- VAT invoices

Healthcare market research questionnaires, healthcare studies, pharmacovigilance, drug safety, pharmaceutical documents, labelling, product characteristics, patient information leaflets, patient reported outcomes, informed consent forms, registration dossiers, marketing, training courses, medical devices, operation and maintenance manuals, regulatory compliance, software, packaging inserts, labels, manufacturing process descriptions, catalogues, contracts, clinical trials, medical records