Regulatory Operations Associate

Regulatory Operations Associate

JR107219

Site: São Paulo -  Brazil

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
 

Responsibilities:

• Provide support for submissions and other documents by performing necessary tasks including assembly, dispatch and coordinating resources for submissions to CTIS.
• Maintain submission components associated with a regulatory submission, as required.  This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking .
• Perform quality review of Regulatory Operations team members work to ensure accuracy.
• Participate in submission teams, maintaining necessary liaison between both project leader, and when applicable, with client.
• Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required.
• Maintain current knowledge of applicable regulations and industry best practices.  Participate in the interpretation of guidelines and impact assessment to current work procedures.  Anticipate Regulatory consequences and advise project teams on publishing issues and strategies.
• Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and government agencies in a polite and professional manner.
• Assist in the design and implementation of new processes or initiatives within the department.
• Participate in special projects and carry out assigned activities in support of the Publishing function.

What you will need:

·         Microsoft Office

·         Advanced English for Writing / Reading / Speaking

·         A high school diploma and/or equivalent.

·         Desirable Clinical Trials exp. but not essential

·         Degree in Health is a plus.

·         Previous experience in administration is preferred

·         Excellent communication skills

·         Ability to work independently.

·         Ideally you will have 1-2 years relevant experience

To be successful in the role, you will have:
 

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.

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