Taiwan Regulatory & Site Activation Specialist — Clinical Trials

Worldwide Clinical Trials; United States; À distance; USD 90 000 - 130 000; Plein temps

Résumé du poste

Worldwide Clinical Trials is a global midsize CRO seeking a Regulatory Affairs professional to drive regulatory submissions, coordinate translation reviews, and maintain country-specific labeling and consent materials. The role requires a medical/biological sciences background, strong English skills, and experience with ICH GCP guidelines.

Successful candidates will collaborate with SAR teams across NA and international markets, ensuring compliant and timely regulatory activities in a fast-paced

Qualifications

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or related sciences.
• Multilingualism preferred; working knowledge of English.

Responsabilités

• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with high quality.
• May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, labels, etc.
• Maintain country-specific patient information sheet and consent form customization text, and country-specific drug labeling information and Country Intelligence Pages.
• Review and make recommendations on documentation to comply with ICH GCP & country-specific requirements.

Connaissances

Regulatory submissions

Translation review

MS Office

Time management

English communication

Formation

Four-year college degree in sciences

Outils

MS Word

Excel

PowerPoint

Description du poste

Worldwide Clinical Trials is a global midsize CRO seeking a Regulatory Affairs professional to drive regulatory submissions, coordinate translation reviews, and maintain country-specific labeling and consent materials. The role requires a medical/biological sciences background, strong English skills, and experience with ICH GCP guidelines.

Successful candidates will collaborate with SAR teams across NA and international markets, ensuring compliant and timely regulatory activities in a fast-paced