Regulatory Publishing Specialist

As a Regulatory Publishing Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Serves as a subject matter expert in clinical document preparation and document management system processes and procedures, which include compilation of granular clinical study reports and other regulatory documents
• Performs document formatting reviews and remediation to ensure compliance with style and submission-readiness requirements
• May act as a liaison with functional area teams to coordinate document finalization and assist in developing clinical submission content/document plans
• Serves as a technical expert for teams regarding the regulatory EDMS and regulatory publishing/submission-readiness requirements
• Acts as a liaison with functional area teams to coordinate appendices collection and document finalization

You are:

• Bachelor's degree
• 2 years of relevant experience in regulatory publishing
• Working knowledge of the requirements of report-level publishing and virtual document creation preferred
• Good working knowledge of Microsoft Office and Adobe Acrobat
• Basic knowledge of electronic regulatory submissions and records management (e.g. ICH E6, CFR 21 Part 11)
• Strong written and oral communication skills
• Strong attention to detail
• Strong project management skills
• Basic ability in electronic document creation, management, and finalization

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.