Ref #: 32263

Employment type: Permanent - Full-Time

Location: Chile

Description

The Role:
• Preparation of local Clinical Trial Application (CTA) package and amendments
With Affiliate Regulatory team:
• Ensure coordination with regulatory Chemistry Manufacturing and Controls (CMC) and regulatory
operations for package submissions to Health Authority (HA) / Ethics Committees (EC) including
documents as applicable
• Ensure any Health Authority (HA) contacts aligned with Sanofi strategy
With Affiliate Pharmacovigilance (APV):
• Submission of Development Safety Update Report (DSUR) to HA, when applicable
With Corporate:
• Prepare answers to questions from Regulatory Authorities and applicable Ethics Committees

To be successful in the role, you will have:
- At least 3 years’ experience as CTAM (or equivalent position) or At least 4 years’ experience as a CRA
- Action and results-oriented
- Good organization and planning skills
- Risk management
- Excellent negotiation skills
- Critical decision-making
- Excellent communication and strong interpersonal skills
- Business Acumen
- Strong knowledge of drug development, clinical study management, Health Authorities requirements,
ICH, GCP, site management and monitoring
- Advanced knowledge of Microsoft Office application including Word/Excel/PowerPoint
- Self-motivation
- Ability to multitask and manage ambiguity/versatility
- Team leader
- Customer-oriented
- GCP/ICH and experience in the pharmaceutical industry in drug development including clinical
research and Regulatory Affairs
- Excellent knowledge in English (spoken and written)
- Advanced knowledge of Word, Excel, Outlook, Acrobat, Powerpoint, navigating internet


Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.