RECENT WORK EXPERIENCE:

• Exclusively-contracted translator, Chugai Pharmaceutical Co., Ltd. (2017-2021)

• In-house translator, Chugai Pharmaceutical Co., Ltd. (Tokyo; 2012-2017)


PHARMACEUTICAL TRANSLATION EXPERIENCE (extract):


• Extensive translation experience on numerous primary & oncology drugs & indications and virtually all aspects of pharma R&D/ mfg/ marketing including: drug discovery and preclinical/ nonclinical (in vitro cell culture & in vivo animal models/studies on toxicology, mutagenicity, teratogenicity, etc.); CMCs (validation/qualification/pharmacopoeia monographs & specifications/cleanroom & WIP/CIP procedures, bulk drug substance/API manufacturing & release); clinical research/testing & approval/marketing (e.g., clinical laboratory testing & clinical trial procedures, P1-3 trial planning/procedures/protocols, CSRs, PSURs/ ICFs/CRFs/SAPs/GxP docs/adverse event reporting); tumor pathology & histopathology reports; pharmacovigilance; postmarketing (package inserts & product leaflets/PSURs/proper use guidance, recall protocols/drug advertising & marketing restrictions, etc.); pharmacology (PK/ADME/PD/xenobiotics, etc.); marketing authorizations (all eCTD dossier modules, MHLW Shonin marketing approval applications & MAH licensing & import approvals, FDA NDA/EMA MAA-related submissions); other regulatory documents incl. ICH & national health authority communications and MHLW PMDA notifications & consultations; internal & health authority plant inspection & audit reports; counterfeit & falsified medicine issues; pharma industry advocate & doctors advocate group communications; quality/QC/QA (e.g., QMS, CSV, PQS, [re-]validation/[re-]qualification, CAPAs); SOPs on all major pharma procedures from bulk drug storage & transport to CSV and disaster contingency planning; corporate pharma reports & press releases; product lifecycle management & pipeline/portfolio mgmt/strategic policymaking/HR training materials); (bio)statistical analysis; and safety reporting (AEs/ADRs/SAEs/AESIs, etc.)


• Underwent company training on pharmaceutical laws/regulations, ethics and industry standards/issues, and possess working familiarity with industry terminology & data reporting/submission standards & associated formats/data & statistical analysis software macros (MedDRA terminology & CDISC-CDASH/SDTM/ADaM/ODM/ADRGs, etc.)


FREELANCE MEDICAL & PHARMA TRANSLATION EXPERIENCE (extract):


• Approx. 300+ research papers & submitted and/or published abstracts/articles in leading Japanese & international journals incl. Blood, Xenobiotica, NEJM, 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, and Lancet submission on prism adaptation in wheelchair-bound patients with unilateral spatial neglect; familiarity with major medical writing & academic journal style guides

• Extensive (i.e., approx. 20 years) translation & editing experience across virtually all medical disciplines (e.g., radiology, oncology, hematology, surgery, biomechanics & anatomy, cardiology, endocrinology, neurology, clinical psychiatry & behavioral sciences, ENT, dentistry/periodontics/orthodontics/maxillofacial & reconstructive surgery, immunology, genetics, public health science & epidemiology; as well as healthcare economics, nursing, obstetrics/gynecology & reproductive medicine, gerontology, palliative & aged care, anesthesiology & pain management, hospital & patient care modeling, rehabilitation & occupational therapy) and diseases/indications (e.g., blood & solid cancers, hemophilia, diabetes & other metabolic disorders, dementias & other cognitive disorders, osteoporosis, cardiac & pulmonary/respiratory disorders, orphan diseases, tropical diseases & viral infections, antibiotic & other drug resistance, acute & chronic (auto-)immune/inflammatory disorders, and many more.

• United Nations & national health ministry-vetted/contracted translation services provider of intergovernmental communications/reports on emergent public health risks (e.g, clinical development of avian influenza disinfectants, antibiotic/antimicrobial resistance mitigation strategies)

• Book translation: Translation, fact-checking & pre/post-editing of book on radiation health effects authored by leading radiation health expert/emeritus professor Dr. Shigenobu Nagataki


INTERPRETING EXPERIENCE (extract):

• Onsite consecutive interpreter for U.S. radiation & disaster response experts in Fukushima following the earthquake/tsunami & nuclear disaster

• WTO-level patent infringement mediation/arbitration cases (simultaneous & consecutive)

• United Nations (UNFCCC) COP10 Nagoya official side event on biodiversity (booth/simultaneous)

• Familiarity with UN-standard booth equipment (I am a postgraduate trained JA<->EN conference interpreter

PATENT & IP EXPERIENCE (extract):

• Four years as inhouse translator/interpreter for a leading Tokyo-based patent & trademark firm founded in 1914

• Extensive translation of technical patents & utility models (chemical, pharmaceutical, electrical, engineering, medical & mechanical)

• JPO office actions & 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 

EDUCATION:

• Master of Arts in Japanese Interpreting & Translation (MAJIT), 2001, University of Queensland

• Bachelor of Arts in Japanese & Economics, 1997, University of Queensland

QUALIFICATIONS & ACCREDITATIONS:

• NAATI* accredited JA->EN Professional Translator (2009)

• Board of Editors in the Life Sciences (BELS)-accredited editor (2013)

• Japanese Language Proficiency Test Level 1 (2002) 

• American Medical Writers Association (AMWA) Essential Skills (2015) & Regulatory (2018) certification

• SDL Trados Advanced Users Course (2015)