Country Start Up Specialist

Job Summary

As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining vital experience in study start up. You will be a productive member of the team, and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators, you will gain valuable hands-on experience to enable you to develop a career in clinical research.

Responsibilities

• Provide day-to-day departmental/project support activities, such as collection of vital documents for ethics submissions and preparation of study documents to competent authorities;
• Support Regulatory Submission Managers and Start Up teams in ensuring deadlines are adhered to;
• Conduct quality control of documents;
• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
• Perform other tasks as needed.

Qualifications

• Bachelor's degree is required (preferably in a Life Sciences field) and at least 3 - 4 years of regulatory submissions experience;
• Excellent organizational and prioritization skills;
• Knowledge of Microsoft Office;
• Great attention to detail and excellent oral and written communication skills;
• Fluency in spoken and written English.

We kindly ask to submit applications in English.