Compliance Administrators & Support 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.

Work closely with R&D and R&D Quality partners to support users to navigate QMS system (TrackWise) to input information related to audits, inspections, deviations, CAPA and change control Workflows.

Works closely with R&D Quality Regulatory Intelligence Subject Matter Experts to ensure regulatory information is cascaded appropriately and monitored in existing trackers.

Works closely with R&D Quality Compliance Leads to support the Global Document Gap Assessment process to ensure new and revised documents are assessed by appropriate SMEs and monitored in existing trackers.

• Is accountable for end user support for use of and troubleshooting of system issues.
• Liaise with IT for responses to system issues.
• Provides guidance on QMS Systems and related IT systems as needed to support end user capabilities.
• Support Global Quality Document gap assessment process by disseminating pre-filled gap assessments to appropriate Subject Matter Experts.
• Is responsible for monitoring global document gap assessments through completion, including applicable action items, through a centralized tracker.
• Works closely with R&D Quality Regulatory Intelligence lead to distribute regulatory information and maintain regulatory information and assessment trackers.
• Input data into TrackWise in support of R&D and R&D Quality as a system administrator as needed.
• Support the TrackWise Account Request Management process for in support of R&D and R&D Quality and those staff members seeking Trackwise workflow access
• Research and conduct data queries to answer questions during audits and inspections

• Bachelor's degree in a science, business or technical related field is required
• Minimum 2 years in R&D or Quality Assurance in a Pharmaceutical or Medical Device environment supporting GxP system is required
• Previous experience with Quality Management System technologies (TrackWise experience desired)
• Inspection support experience is desired.
• Strong analytical skills with the ability to prioritize multiple priorities
• Collaborative team player with a positive attitude who has the ability to think and act quickly and identify creative solutions to complex problems
• Strong attention to detail with the ability to articulate quality related risks and potential impact.
• Excellent communication and interpersonal skills.
• A self-starter, who motivates, has tact and diplomacy and is able to define and prioritize tasks within a project.
• Strong knowledge of MS Word, Excel, PowerPoint & Outlook


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.