Regulatory Publishing Specialist 2

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.

Who are you?

You are a leader that isn’t afraid to delegate, but also isn’t afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate planner and coordinator and are an excellent communicator. You have a serious passion for regulatory publishing and submissions. You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

What you will be doing:

Provides publishing support in the development of global regulatory submissions.

Primary Responsibilities

• Serves as primary point of contact and publishing Subject Matter Expert (SME) on product Global Regulatory Team (GRT) meetings, guiding the team on eCTD and regional submission requirements.
• Compiles and publishes eCTD, NeeS, and other electronic regulatory submission types.

Level Specific Responsibilities

• Acts as primary product-aligned publisher according to SOPS and within established timeframes.
• Provides strategy on planning and publishing timeframe required for a specific submission.
• Works independently to drive publishing process for routine submissions.
• Collaborates with other submission publishers to assure standard practices and quality submission outcomes
• May provide report- or document-level publishing as needed, but primarily supports submission-level publishing
• Educates document authors on technical submission formats and lifecycle management and regional submission requirements.
• Acts as submission coordinator on project teams for functional or cross functional submissions of high complexity that do not have a submission manager/regulatory project manager assigned
• Promotes submission publishing efficiencies by promoting re-use of documents, adopting global dossier principles and standardizing processes to enable simultaneous compilation and publication of submissions.
• Performs quality control review of submission component documents to client and regulatory agency specifications.
• Proactively identifies and escalates publishing issues as necessary.
• Actively participates in local and global publishing meetings to ensure publishing processes are consistent among regions.
  
  

• Bachelor’s degree in relevant field of study.
• 1 year of relevant experience or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above.
• All employees must read, write and speak fluent English and host country language.
• Intermediate knowledge of regulations governing pharmaceutical/eCTD submissions
• Proficiency in use of electronic submission publishing tools and/or document management systems
• Excellent communication, interpersonal and time management skills
• Ability to work autonomously under limited direction
• To qualify, applicants must be legally authorized to work in the United States or Canada, and should not require, now or in the future, sponsorship for employment visa status

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.