Document Specialist (Non-Clinical)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. 

The Nonclinical Document Specialist assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

What you will be doing: 

• Within the regulatory document management system:
• Generates quality and nonclinical basic structures and content for regulatory submissions. 
• Ensures relevant regulatory-authority compliant document naming conventions are applied to components.
• Imports and creates documents for regulatory submissions including referenced literature and reference lists
• Submission document editing, including:
• Cross reference and update of reference list citations against in-text references
• Creation of abbreviations list within documents
• Creating intra-document and inter-document hyperlinks between documents that meet company submission ready standards
• Formatting, conversion, or retyping of data tables using the Authoring Tool (MS Word, MS Excel)
• Submission readiness conformance with house-style, sponsor's submission ready standards and regulatory agency requirements:

• Formats Word documents
• Performs PDF editing
• Ensures submission documents are navigable
• Converts quality submission documents

• Contributes to the preparation and maintenance of submission document templates.
• Participates on project teams related to deliverables standards or harmonization or procedures within the team scope.

You are: 

• Bachelor’s degree or equivalent industry-relevant experience
• Expertise in using Document Management System gained in a pharmaceutical environment, eg, Documentum in order to be able to support and train
• Experience in understanding nonclinical dossier structures and advanced knowledge of common file formats (eg, Word) and related publishing tools (eg, ISI Toolbox, Adobe Acrobat, eCTDXPress)
• Knowledge of regulatory authorities’ requirements on electronic submissions in several regions (eg, US, Europe, etc.)
• Highly developed influencing skills and interactive communication when interacting with people at all levels and within teams
• Demonstrated ability to set and manage priorities, resources, goals and project initiatives
• Experience working in cross-functional, global project teams.

Compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level

What ICON can offer you: 

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. 

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.  

Our benefits examples include: 

• Various annual leave entitlements 
• A range of health insurance offerings to suit you and your family’s needs 
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead 
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being 
• Life assurance 
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others 

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits 

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 or submit a request here.  

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.