Regulatory Document Translator
5 days ago
About the Job:
ProductLife Group is seeking a highly skilled Regulatory Document Translator to join our team.
The successful candidate will be responsible for translating various pharmaceutical-related documents, including regulatory documents, clinical trial protocols, drug labels, and medical reports.
Key responsibilities include ensuring translations meet regulatory requirements and are aligned with industry standards such as ICH, FDA, EMA, and MFDS.
The ideal candidate will have a strong understanding of pharmaceutical regulations, clinical research processes, and medical terminologies.
Responsibilities:
- Translate regulatory documents, clinical trial protocols, drug labels, medical reports, SOPs, and other pharmaceutical-related content from Korean to English and English to Korean.
- Ensure translations meet regulatory requirements and are aligned with industry standards such as ICH, FDA, EMA, and MFDS.
- Proofread and review translated materials to maintain accuracy, consistency, and clarity.
- Work closely with Regulatory Affairs, Clinical Research, and Pharmacovigilance teams to interpret technical documents.
- Assist in the localization of product information, including drug inserts, leaflets, and marketing materials for the Korean market.
- Maintain a glossary of technical and regulatory terms to ensure consistency across translations.
- Stay updated on pharmaceutical regulations and industry terminology in both Korean and English.
- Support meetings, conferences, and training sessions as an interpreter when required.
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