Korean Linguist - LS/CRO

Educational Background:

 University degree in Translation/Applied Languages/Linguistic Studies or Degree in Medicine, Biology, Biochemistry, Clinical Research, or a related life sciences field, or equivalent combination of education and experience (University degree in other fields plus 2 years of full time experience in translation; OR 5 years of full time professional experience in translating

Industry Experience:

 Experience working at a local and/or global pharmaceutical company or Contract Research Organization (CRO — a company hired by pharma/biotech firms to conduct clinical trials and research on their behalf). This experience can come from a variety of roles, such as:

• Clinical or scientific researcher (designing or running trials, analyzing data)
• Pharmacovigilance specialist (monitoring and reporting drug safety and adverse events)
• Regulatory affairs expert (managing submissions to health authorities like the FDA or EMA)
• Or similar scientific/medical functions

Translation Experience：

 5+ years translating clinical research and medical documents across multiple therapeutic areas (e.g., oncology, cardiology, rare diseases, CNS).

Document Expertise The ideal candidate has hands-on translation experience with the following document types:

Clinical Research Documents

• Protocols and synopses — the master plans that define how a clinical trial is designed and conducted
• IB (Investigator's Brochure) — a comprehensive reference document summarizing a drug's clinical and non-clinical data for trial investigators
• ICF (Informed Consent Form) — the document patients sign before enrolling in a trial, explaining risks and procedures
• Patient Sheets and Patient Diaries — materials written for trial participants to track symptoms, medication intake, and daily health data

Regulatory Documents

• SmPC (Summary of Product Characteristics) — the official document describing a medicine's properties and conditions of use, reviewed by health authorities
• PIL (Patient Information Leaflet) — the package insert found inside a medicine box, written for end patients
• Labels — the physical labeling on drug packaging
• CTD Modules (Common Technical Document) — the standardized format used to submit a new drug application to regulatory authorities worldwide (e.g., FDA, EMA)

Pharmacovigilance Documents

• • PSUR (Periodic Safety Update Report) — a regular report submitted to regulators summarizing a drug's benefit-risk profile over time
  • DSUR (Development Safety Update Report) — similar to a PSUR but for drugs still in clinical development
  • RMP (Risk Management Plan) — a document outlining strategies to identify, prevent, or minimize risks associated with a medicine
  • SAE and AE reports (Serious Adverse Event / Adverse Event) — individual case safety reports documenting unexpected or harmful reactions in patients