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 by delivering quality and excellence in regulatory and site activation work for clinical research. We are a diverse, inclusive team of 3,500+ experts committed to collaboration and creativity.

What You Will Do

• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and 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, etc. to comply with ICH GCP and country-specific requirements.

What You Will Bring To The Role

Your Experience

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and to cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

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