Korean Linguist - LS/CRO

Job Description Summary

This role involves managing translation and copy-editing tasks, ensuring high-quality linguistic deliverables for assigned projects or accounts. Responsibilities include coordinating with freelancers and agencies, maintaining language resources, resolving terminology queries, and collaborating with clients and internal teams to enhance workflow efficiency. Job Reference: #LI-JC1

The following is a non-exhaustive list of responsibilities and areas of ownership for this role:

• Performing copy-edit tasks on assigned projects or accounts
• Performing on-demand translation tasks
• Performing lead support on assigned projects or accounts
• Managing and maintaining the language materials (including glossaries, Style Guides, work instruction) up to the quality standards and up to date as required by the account or project
• Managing project-related queries
• Ensuring good interaction among team members and resolving questions on terminology and language matters
• Testing and qualifying new freelancers and vendors as required
• Developing and training of internal linguists and external partners according to the accounts’ and Welocalize’s needs
• Interacting with clients on linguistic matters as required
• Participating in the development of new and improved working processes
• Meet or exceed the KPIs in terms of productivity, on time delivery, quality

Requirements

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