Medical/Technical Translator

Job description

Job Description

The successful candidate will provide high-quality, regulatory-compliant English translations of regulatory documents required for product submissions, approvals and launches worldwide.

Major Accountabilities:
- Independently translates regulatory documents relating to Swiss product approvals such as prescribing information texts, patient leaflets, approval letters, Swissmedic correspondence, etc. from German to English using the group’s translation/terminology software;
- Translates other regulatory-relevant documents into English, primarily from German but where possible also from other languages, using the group’s translation and terminology software;
- Performs detailed linguistic review of Global Labelling documents such as Core Datasheet, Basic Patient Leaflet, International Package Leaflet, Basic Succinct Statement in order to a ensure high level of document quality and consistency of terminology;
- Participates in the process of identifying, testing and selecting external expert English translation vendors (freelance individuals and translation agencies specializing in medical and pharmaceutical translation);
- Outsources translations to such vendors as required and monitors the general quality of their output through systematic revision, providing feedback and taking corrective actions if necessary;
- Updates and maintains in-house medical and pharmaceutical terminology database (MultiTerm);
- On request, provides support relating to translation activities for EU centralized approvals (creation of bookmarked pdfs, English language reviews, etc.);
- Keeps himself/herself up-to-date with relevant related guidance such as EMA templates and terminology requirements;
- Is the advisor on English language-related matters for Drug Regulatory Affairs (DRA) colleagues.

Desired profile

Minimum requirements

Education:
- University degree in modern languages, preferably coupled with experience in bioscience.
- Post-graduate qualification in translation is desirable.

Language:
- Excellent command of written and spoken English (mother tongue expert linguist level)
- Fluency in German
- Other languages (in particular French) are desirable

Professional Experience:
- At least 3 years’ experience as a medical/pharmaceutical translator
- Experienced user of SDL Studio software