Working languages:
English to Spanish

Isabel Callaway
Medical Devices and Pharma Translations

United States
Local time: 00:17 PST (GMT-8)

Native in: Spanish (Variants: Standard-Spain, Latin American) 
Account type Freelance translator and/or interpreter, Identity Verified Verified site user
Data security Created by Evelio Clavel-Rosales This person has a SecurePRO™ card. Because this person is not a ProZ.com Plus subscriber, to view his or her SecurePRO™ card you must be a ProZ.com Business member or Plus subscriber.
Services Translation, Editing/proofreading
Expertise
Specializes in:
Medical: InstrumentsMedical: Pharmaceuticals
ManufacturingBusiness/Commerce (general)
International Org/Dev/Coop

Rates
English to Spanish - Rates: 0.10 - 0.15 USD per word
KudoZ activity (PRO) PRO-level points: 12, Questions answered: 17
Portfolio Sample translations submitted: 3
Translation education Bachelor's degree - University of Phoenix
Experience Years of translation experience: 14. Registered at ProZ.com: May 2013.
ProZ.com Certified PRO certificate(s) N/A
Credentials N/A
Memberships Society of Clinical Research Associates (SOCRA)
Software Adobe Acrobat, Microsoft Excel, Microsoft Office Pro, Microsoft Word, Skype, Powerpoint, SDL TRADOS
Training sessions attended Attended 7 training sessions

Professional practices Isabel Callaway endorses ProZ.com's Professional Guidelines (v1.1).
Bio
An accomplished administrative clinical and regulatory affairs professional with over 9 years of experience in the medical devices and pharmaceutical industries. Fast, reliable and accurate translator from English to Spanish with emphasis in translation of clinical trials from proof of concept to post-market surveillance.

Areas of translation expertise:
• Proof of Concept documentation
• SOPs and work instructions
• Study start-up
• Informed Consents
• Subject manual
• Monitoring reports
• Physician and patient questionnaires
• Scientific literature and publications
• News press communications
• Marketing catalogs, brochures, posters and presentations
• Study protocol and amendments
• FDA and IRB Submissions
• Subject recruitment
• Investigator manual and brochure
• Case Report Forms (CRFs)
• Adverse event reports
• Labeling
• CE mark application
• Marketing Surveillance and literature

Deep understanding of concepts, regulations and terminology pertinent to the clinical research field. Strict adherence to the Food and Drugs Administration (FDA)/European Community (CE) regulations, and Good Clinical Practices (GCP)/International Conference of Harmonisation (ICH) guidance and HIPPA regulations.
Ability to produce fast and accurate translations using medical, regulatory and technical terminology, as well as layman language, according to targeted audience and localization requirements.
Previous work experience as Clinical Trial Administrator in medical communications (Oncology and inflammation fields) for the pharmaceutical industry, as well as clinical trial administration experience in retinal and cochlear implants for the medical devices industry.
Native of Chile with a Bachelor of Science in Business Management from University of Phoenix.
This user has earned KudoZ points by helping other translators with PRO-level terms. Click point total(s) to see term translations provided.

Total pts earned: 12
(All PRO level)


Language (PRO)
English to Spanish12
Top general fields (PRO)
Medical4
Bus/Financial4
Other4
Top specific fields (PRO)
Business/Commerce (general)4
International Org/Dev/Coop4
Medical: Pharmaceuticals4

See all points earned >
Keywords: English, Spanish, Clinical Trials, Medical, Devices, Pharmaceutical, Drugs, Marketing, Latin America, localization, Regulatory, submissions, Clinical Research, Clinical Studies, Medical Instruments.


Profile last updated
Mar 5, 2014



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