Regulatory Publishing Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Position overview:

As a Senior Regulatory Publishing Specialist, you will work within one of PRA’s key client partnerships with responsibility for publishing and submission support in the development of global regulatory submissions to Health Authorities.

Key tasks will include:

• Acting as the primary publisher for various regulatory submissions (including NeES, eCTD and paper formats), setting the strategy for the submission
• Planning and publishing of the lifecycle submissions portfolio, with accountability of monitoring the submissions forecast and managing timelines and quality
• Liaising with other stakeholders, including Regulatory Affairs, Submission Managers etc to ensure submission requirements and timelines are agreed upon
• Analyse regulatory guidelines and regulatory documentation practices to ensure compliance
• May also serve as Subject Matter Expert for various publishing tools or dossier types

Focused primarily on the lifecycle submissions portfolio, you may also work on departmental initiatives, process improvement, validation testing or highly-complex submissions.

You are:

Tenacious, collaborative and keen to learn new ways of working.

Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• Proficiency in regulatory publishing across Europe or globally
• The ability to adapt to new ways of working and learn new processes
• Experience with eCTDXpress and/or Liquent IP preferred but not essential
• A strong understanding of regulatory requirements and submission processes
• Fluency in English
• Bachelor’s degree in a relevant field of study

 
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.