Traditional Chinese (Taiwan) Senior Linguist
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AI Summary
About Welo Life Sciences
Welo Life Sciences, a Welo Global brand, is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations operating in regulated global markets. We deliver regulator-ready translation, linguistic validation, and localization solutions that support clinical trials, pharmacovigilance, regulatory affairs, labeling, and global commercialization. Our approach combines subject matter expertise with ISO-certified quality processes and technology-enabled workflows designed to integrate seamlessly into life sciences operations. With extensive experience supporting global product development and post-market requirements, Welo Life Sciences helps organizations accelerate timelines, protect data integrity, and maintain compliance across languages and regions. All solutions are delivered within a secure, audit-ready framework supported by seven ISO certifications. welolifesciences.com
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. The position also supports broader team efforts through editing, error arbitration, and active participation in quality initiatives.
Job Reference: #LI-JC1
\n- 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 linguist role on assigned accounts
- Taking ownership of deliveries that were translated internally or by external partners for one or more accounts into their target language
- Preparing, 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
- Coordinating with freelancers, agencies and internal linguists on assigned projects or accounts
- Testing and qualifying new freelancers and vendors as required
- Developing and training of internal linguists/new and existing freelancers 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. Propose process improvements.
- Meet or exceed the KPIs in terms of productivity, on time delivery, quality
- Achieving the goals set by the team manager
Educational Background:
Degree in Medicine, Biology, Biochemistry, Clinical Research, or a related life sciences field.
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
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