Regulatory Operations Assistant
JR107213
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:
• Uploads CTIS documentation of EMA portal
• Responsible for coordinating all aspects of document level publishing for internal review and signoffs.
• Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines
• Maintain submission components associated with a regulatory submission, paper and/or electronic, as required. This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking
• Assemble electronic PDF and paper Regulatory Submissions and packages for US Food and Drug Administration, the European Medicines Agency, Health Canada, and other international regulatory authorities
• Prepare shipping documentation
• 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.
• Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and clients.
• Assist in the design and implementation of new processes or initiatives within the department.
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 but not essential.
· Excellent communication skills
· Ability to work independently.
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.
#LI-FB1
