I have been translating/proofreading pharmaceutical documents since 2009 and have extensive experience with clinical trial documentation (Clinical Trial Agreements, IBs, Study synopsis and design, ICFs, regulatory approvals), patient diaries, SPCs, PILs, questionnaires, IFUs, user manuals and software interfaces for medical devices, SOPs, brochures, packaging and labelling, medical reports.

- SOPs (Standard operating procedures), and patient information leaflets/Consent Forms
- Protocols
- Dosing diary description
- health and well-being campaigns
- health-related benefits and diet programs
- health insurance plan information
- data sheets on chemicals and health exposure
- application and use medication and cosmeceuticals
- reports on pharma studies
- safety data sheets
- Clinical trials: ICFs, patient diaries, subject recruitment mater, clinical trials agreements

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

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

- 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.

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.

PgCert in clinical trials (Univ. of Edinburgh). Examination-based translator certificate issued by the Romanian Ministry of Culture (medicine and pharmacy). A member of the European Medical Writers' Association.
All types of EMA submissions and materials, 2 years as a subcontracted editor for EMA. Clinical trial documentation, including regulatory, contracts and insurance. Lab manuals and reports. Implantable devices (neurology, cardiology). Regular professional development courses.

BA in Psychology

Romanian native speaker translator with 17 years of experience in translations in various fields including medical field. My areas of expertise in this field:
- Clinical trials protocols, SOPs, PILs, SPC
- Packaging and labels
- Informed Consent Forms
- Patient Information Sheets
- Marketing brochures
- Questionnaires
- Data sheets on chemicals and health exposure
- Occupational safety and health materials
- Brochures and booklets for different diseases

I am a full-time professional linguist with extensive expertise in clinical trials acquired through many years of work in this field — making up around 75% of my work over the past 4 years, with over 1 million words translated and edited. I have experience coordinating linguistic validation projects. Types of documents: Summary of Product Characteristics, Labeling and PILs, Marketing Authorization Applications, SOPs, Laboratory Manuals, Chemistry Analyzers, EMA regulatory documents, etc.

I am an experienced English to Romanian translator with over 7 years in translating various documents in the medical field: medical questionnaires and brochures, clinical trials, clinical protocols, data sheets, informed consent forms, package inserts and labels, summaries of product characteristics, Instructions for Use (IFU), patient information leaflets etc.

Relevant experience in translating SPCs, PILs, CRFs, Informed Consent Forms, Instructions for Use, Clinical Trial Protocols and all associated materials, Investigator's Brochures, questionnaires for both physicians and patients, pharmacovigilance activities, training manuals for medical representatives, marketing materials, Contents of two websites (part of an MS patient support program) for Multiple Sclerosis medicines

Translating in this field since 2009. Blue books, clinical trials, informed consent, case report forms, IBs, research protocols and protocol amendments, instructions for investigators, SOPs, SmPC, IFUs, patients diaries, patient information, ICF/PIS, marketing authorizations, medical equipment and lab instruments, treatment related toxicity, safety summary, response summary, SUSAR, SAEs reports and many other. Also translated for: Alteco Medical AB, Parexel, Argenx, Aviagen, Sandoz.

Clinical trials (protocol synopses, ICFs, PILs, CRFs, patient/subject diaries and surveys, PROs, IBs, service agreements, regulatory documents, patient recruitment documents)
Operation manuals and IFUs for medical instruments and devices
Abstract collections on sleep apnoea
Information brochures on cancer awareness and prevention
Test results, pharmacology reports, AE reports
SmPCs, PILs, labels for medicinal products (incl. medicinal gases)

- Science Degree: specialization in Organic Chemistry;
- Clinical trials;
- Health care applications for mobile devices;
- Services Agreements - pharmaceutical fields
- Covering Letters for clinical trial protocols
- Information relating to the Research and Development of chemicals,
- Summary of Product Characteristics, Labeling and PILs,
- EMA regulatory documents