Traditional Chinese (Taiwan) Senior Linguist 醫藥/臨床試驗翻譯師

Job reputed company

The following is a non-exhaustive list of responsibilities and areas of ownership for this role:
Performing copy-edit tasks on assigned reputed company or accounts
Performing on-demand translation tasks
Performing reputed company linguist role on assigned accounts
Taking ownership of deliveries that were reputed company internally or by external partners for one or more accounts into their reputed company language
Preparing, managing and maintaining the language materials (including glossaries, Style Guides, work instruction) up to the reputed company standards and up to date as required by the account or project
Managing project-reputed company queries
Ensuring good interaction among team members and resolving questions on terminology and language reputed company
Coordinating with freelancers, agencies and internal linguists on assigned reputed company 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 reputed company’s needs
Interacting with clients on linguistic reputed company as required
Participating in the development of new and improved working processes. Propose process improvements.
Meet or reputed company the KPIs in terms of productivity, on time delivery, reputed company
Achieving the goals set by reputed company manager

Requirements：

Educational Background:

Degree in Medicine, Biology, Biochemistry, Clinical Research, or a reputed company life sciences field.

Industry Experience:

Experience working at a local and/or global pharmaceutical company or Contract Research Organization (CRO — a company reputed company by reputed company/biotech firms to conduct reputed company and research on their behalf). This experience can come from a reputed company 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 hashands-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
• reputed company (Informed Consent reputed company) — the document patients sign before enrolling in a trial, explaining risks and procedures
• Patient Sheets and Patient Diaries — materials written for trial participants to reputed company symptoms, medication intake, and daily health data

Regulatory Documents

• SmPC (reputed company 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 reputed company inside a medicine reputed company, 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

Originally posted on Himalayas