Japanese to English translator and checking

Translator Tc131

Academic experience backed by strong professional experience, this translator has vast experience in the field of biochemistry and molecular biology. He has more than 8 years of translation experience. He is an American English native and is fluent in English, Japanese and other languages like Mandarin Chinese, Spanish, and German. He is proficient in Japanese to English translation and checking.

Areas of expertise

Biochemistry, biostatistics, genetics, histopathology, pharmaceutical research

Highlights

- Japanese-Language Proficiency N1 Level Certification, 2010
- Contact Partnership Scholarship Recipient, University of California, Education Abroad Program
- Awarded Dean’s Honor List

Years of experience

Country

Japan

Education and Training

MD Rush Medical College, Chicago, Illinois, US.
BA Molecular and Cell Biology, Genetics and Development, University of California, California, US
Medicine Resident, Fox Valley Family Medicine Residency Program, University of Wisconsin School of Medicine and Public Health, Appleton, US
Graduate Diploma, Biochemistry, University of California Education Abroad Program, University of California, California, US

Work experience

Drug Safety Consultant, Brand Institute, Miami, Florida
- Ensured that drugs met regulatory standards set forth by the FDA, the European Medicines Agency, Health Canada, and the Ministry of Health, Labour and Welfare in Japan.
- Provided medication error prevention analysis associated with the labeling of pharmaceuticals, biological products, and medical devices.
- Performed in-depth analysis of issues related to prescribing and dispensing, including consulting on all aspects of drug information, from profile to packaging to trade-dress.
- Coded in Visual Basic, a screening tool that evaluates Katakana drug names for scripted similarities with existing drug names as per Japanese regulatory requirements.
Bio-technician, Bayer HealthCare, Berkeley, California
- Involved in managing constant perfusion fermentation and cell separation systems, operating and troubleshooting ultrafiltration technology and sampling for quality control
Production Technologist, Bayer HealthCare, Berkeley, California
- Played leadership roles in environmental safety, Six Sigma, and CIP (Continuous Improvement Process) projects

Translator of Pharmaceutical and Biochemistry Subject

Translator PT29

This translator is a Pharm.D. in Pharmacy and Biochemistry from University of Sao Paulo and has more than 10 years of translation experience. He is a member of the Society for Clinical Data Management and is currently a Clinical Data Quality Manager at Bristol-Myers Squibb, Brazil. He has advanced knowledge of clinical operations, data management, budget and contracts, SAE/eSAE processing, management and monitoring of clinical trials, onsite monitoring, vendor management, Phase IIV clinical development, post-marketing trials, regulatory compliance, clinical pharmacology, medical writing, drug supply, and IVRS processes.

Areas of expertise

Pharmaceutical research, Pharmaceutical chemistry, Pharmacotherapy, Cancer research, Food microbiology, Molecular biology, Histopathology, Nucleic acid research, Metabolism, General biochemistry, Dermatology, Cardiology, Endocrinology/Ophthalmology, Gastroenterology, Hepatology, Immunology, Infectious Diseases (HBV, HCV, HIV), Neurology, Oncology/Immuno-Oncology, Ophthalmology

Years of experience

Country

Brazil

Education and Training

Doctor of Pharmacy (Pharm.D.), Pharmacy and Biochemistry, Universidade de São Paulo, São Paulo, SP, Brazil
Data Management for Clinical Research, Vanderbilt University, USA

Work experience

Clinical Data Quality Manager, Bristol-Myers Squibb Company, Brazil
- Manage the data collected from 12 clinical trials distributed among 63 clinical sites in Brazil plus 6 clinical trials conducted in Canada.
- Revision of quality metrics and data trends.
- Performance of clinical listing review per Data Review Plan.
- Site support on Serious Adverse Event reporting and follow-up.
- Support sites with account registration for company’s systems.
- Training/coaching on CRF/eCRF completion.
- Data cleaning, eCRF application (coordination of Data Early Process Control and Ongoing Data Quality Control activities).
- Provision of ongoing feedback on Oracle Clinical system validations/eCRF instructions and escalation of any data issues to upper managers.
Clinical Research Associate, PPD do Brasil Suporte à Pesquisa Clínica / PPD Intl, Brazil
- Phase II/III Diabetic Macular Edema (DME) trial
- Phase I Anticonvulsant Therapy trial
- Phase III Lupus Nephritis trial
- Phase II Respiratory Syncytial Virus (RSV) trial
Jr. Clinical Research Associate, AAIPharma/IPCSP, Brazil
- Elaboration of clinical trial protocol, Informed Consent Forms (ICF) and Case Report Forms (CRF).
- Translation of protocols, ICF, paper CRFs and trial-related manuals and contracts.
- Electronic CRF training; certified e-CRF trainer Site Initiation Visits and Interim Monitoring Visits (IMV), monitoring reports, management and report of Serious Adverse Events, regulatory management, import and distribution of investigational products to sites, export of biological samples to central laboratories, clinical data management, organization and leadership of an Investigators’ Meeting.
- Development and improvement of management tools for internal administration, monitoring visits and clinical trials.
- Creation of electronic CRF, electronic monitoring forms, electronic SAE report form and electronic monitoring expenses report form (incorporated to the company’s portfolio and SOP).
Translation Technical Manager, R A Serviços de Traduções Médicas e Científicas Ltda, Brazil
- Translation of Clinical Trial Protocols, Investigator’s Brochures, Safety Reports, Regulatory Letters and Documents, Case Report Forms, Informed Consent Forms, Academic Articles.
- Management, training and follow-up of a team of 192 translators.
- Management of the company and assignment of duties to employees.