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Extensive experience in translation of clinical trial documents for world’s leading pharmas & healthcare companies. Drug indications include macular degeneration, lower & upper limb spasticity, chronic myeloid leukemia, neuropathic pain, fibromyalgia, hemophilia, and hepatocellular carcinoma, lumbar disc hernia & many more; device trials include negative pressure wound treatment system, catheter sets, stents, syringes and more.
Considerable work on ICH CTDs including CSRs, PSURs, ICFs, CRFs, GMP, GQP & Japan GCP/GPSP-related documents as well as clinical protocols
PMDA clinical study review notifications for drug-eluting vascular stents and PMDA consultation for erythropoietic-stimulating agent indicated in renal anemia
Package inserts for catheter sets & insulin syringes for global medical device maker, in vitro diagnostics materials (particularly catheters & immunoassay kit user guidelines), and ultrasound contrast agent
Comprehensive translation of Japanese medical journal articles including Japanese Journal of Toxicology, Japanese Journal of Interventional Cardiology, Journal of Infection & Chemotherapy, Japanese Society of Clinical Hematology, Japan Physicians Association & Japanese Society of Internal Medicine
Extensive work on health care, nursing, rehabilitation including doctor interview transcripts on pain management, anesthesiology & diabetes, research papers on dementia patient care models, various reports occupational therapy (IADL training, gait orthoses), preventive medicine & wheelchair design
Clinical efficacy testing on avian influenza disinfectants and clinical development plans including antibody drug targeting glucocorticoid-induced tumor necrosis factor receptors (GITRs); national health ministry reports on H1N1 ‘swine flu’ and BSE
Numerous (200+) journal article & study translations covering virtually all medical disciplines from diabetes and ACE inhibitor studies to jaw bone biomachanics, syndromic craniosynostosis, myxofibrosarcoma, respiratory syncytial virus, Chagas disease, renal denervation & minocycline-induced pneumonitis (inquire for more details); submission to The Lancet on prism adaptation in wheelchair-bound patients with unilateral spatial neglect
Pharma industry procedures including CSV & supplier evaluation manuals for global healthcare companies; pharmaceutical sales rep. marketing handbooks etc.; familiarity with medical/pharma translation quality assurance software & procedures.
Recent interpreting experience includes:
- WTO-level patent infringement cases (simultaneous & consecutive);
- Simultaneous work at COP10 official side event in Nagoya for Vice Rector of UN University & Vice President of Tokyo University;
- On-site consecutive work for U.S. radiation & disaster response experts in Fukushima;
- Familiarity with UN-standard booth equipment (I am a trained JA<->EN conference interpreter)
PATENT & IP EXPERIENCE (extract):
- Four years as inhouse translator/interpreter for patent office in Tokyo
- Extensive translation of technical patents and utility models (chemical, pharmaceutical, electrical, engineering, medical & mechanical)
- JPO office actions and Tokyo High Court/ Supreme Court decisions
- Trademarks, designs & security agreement work
- Working knowledge of Japanese patent & trademark law/ JPO examination practice/national phase and PCT as well as Madrid Protocol & Community design procedure
Graduate of MAJIT (Master of Arts in Japanese Interpreting & Translation) and BA in Japanese & in economics.
NAATI* accredited JA->EN Professional Translator (exam result: 'Excellent')
*National Accreditation Authority for Translators and Interpreters （Australia)
Japanese Language Proficiency Test Level 1 (2002)
Board of Editors in the Life Sciences accredited (2014)
SDL Trados 2015 Advanced Training Course