Senior Specialist, Regulatory & Site Activation - Chile - Remote

Overview

Senior Specialist, Regulatory & Site Activation - Chile - Remote

Worldwide Clinical Trials is a global, midsize CRO with a mission to improve lives through quality and excellence. We are a diverse, inclusive team of more than 3,500 experts dedicated to advancing the drug-development process for patients and their caregivers.

We are an equal opportunity employer committed to cultivating an inclusive environment that supports collaboration and creativity. All applicants will be considered for employment without regard to race, color, religion, sex, national origin, disability, or any other status protected by applicable law.

What You Will Do

• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis with a consistently high level of 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; maintain country-specific drug labeling information and Country Intelligence Pages.
• Review and make recommendations on all relevant documentation (e.g., labels, patient information sheets, diary cards) to comply with ICH GCP and country-specific requirements.

Your Experience

What You Will Bring To The Role

Seniority level

Employment type

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