Clinical Trials & Life Sciences Linguist (EN–PL) | Protocols, ICFs, Regulatory & Scientific Documentation

24 years translating regulatory and clinical trial documentation for global, multi-country studies. My work covers protocols, informed consent forms (ICFs), SmPCs, CTD submissions, and investigator- and patient-facing materials.

My background is in biology (MSc, Jagiellonian University). In 2020 I completed Harvard Medical School's HMX Pro certificates in Genetics and Immunology, which I draw on regularly when working through dense histopathology, radiology, and oncology source text.

I work with CROs and pharmaceutical, biotech, and medical device companies on documentation governed by ICH-GCP, EU CTR 536/2014, and EMA QRD formatting standards, including eCOA/PRO linguistic validation (forward and back translation, reconciliation, screenshot review). Across large multi-document study sets I keep dedicated project glossaries so terminology stays stable through amendments and translated materials.

I also translate medical records, chemical regulatory documentation including SDS/eSDS, exposure scenarios and other REACH/CLP-related content, pharmaceutical marketing materials, and life sciences patents.

Background: Master of Science in Biology from the Jagiellonian University in Kraków, Poland; Harvard Medical School courses in Genetics and Immunology; academic interests: cancer genomics, immuno-oncology, haematology; experience working in a molecular diagnostics and haematology laboratory.

ProZ Pharmaceutical Translators: https://www.proz.com/pools/pharmaceutical-translators/profile/1402011 

ITI Medical and Pharmaceutical Network

Languages: Polish, English, Spanish

SELECTED CLIENT TYPES

• Top-20 global pharmaceutical companies
• Contract Research Organizations (CROs)
• eCOA/clinical trial technology providers
• Regulatory authorities and bioethics committees — submissions and correspondence
• Scientific and medical publishing houses, including orthodontic and other medical journal articles
• Biotechnology and medical device companies

RECENT MAJOR PROJECTS

• Patients' medical records translated into English — 100,000 words
• Medical glossary development — 300,000 words
• IFUs for coronary stents — 50,000 words
• Documentation and video materials for ICU healthcare professionals treating COVID-19 patients — 50,000 words
• Clinical trial documentation across multiple therapeutic areas, including: COVID-19-related pneumonia, diffuse large B-cell lymphoma, advanced malignancies, non-small cell lung cancer, relapsed small cell lung cancer, glioblastoma, mantle cell lymphoma, Parkinson's disease, myasthenia gravis, Crohn's disease, primary biliary cholangitis, alpha-1antitrypsin deficiency, refractory chronic cough, breakthrough cancer pain and knee osteoarthritis with synovitis
• Documentation for a range of investigational modalities, including small-molecule inhibitors (e.g. SGLT2, PDE4, kinase and PARP inhibitors), antibody-drug conjugates (ADCs), checkpoint inhibitors (anti-PD-1/PD-L1), CAR-T and other cell therapies, T-cell engaging bispecific antibodies (BiTEs), complement inhibitors, monoclonal and polyclonal antibody therapies, and vaccines including mRNA vaccines

SERVICES

• Translation
• Bilingual editing/revision
• Proofreading
• Linguistic Validation
• Linguistic QA
• MTPE (Machine Translation Post-Editing)
• AIPE (AI Post-Editing)
• Terminology management