Job Description

OverviewAs a Clinical Document Specialist you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Clinical Document Specialist provides services that supports the technical aspects of the report-level document production for the authoring community. Familiarity with Clinical Study Reports, Protocols, Investigator Brochures, Briefing Documents, and Response Documents is required.ResponsibilitiesWhat you will be doing:

• Services include, but are not limited to, the technical preparation of submission documents

(individual documents and compound documents). Meets internal document standards with regard
to formatting, timeliness, and submission readiness, with some direct guidance. * Provides publishing services of documents using industry standard publishing tools, includingsubmission ready formatting, hyper-linking, and bookmarking. * Provides document management services including management of documents in the submissionsdocument repository, indexing and archiving of approved documents in accordance with quality
standards. * Performs technical QC.

• Knowledgeable in all aspects of submission-readiness requirements and department processes

#LI-Remote#LI-NR1QualificationsYou are:

• 1 to 3 years experience in document processing activities in the pharmaceutical industry.
• Knowledge of publishing software, electronic document management systems, and intra- and interdocument linking. Strong word-processing skills and proficiency with MS Office and Adobe Acrobat.
• Knowledge of templates and complex document formats.
• In-depth understanding of the document-level processes, and guidelines that impact those

processes. * Proficiency in submission-related HA and Industry regulations and guidelines, as relevant.What ICON can offer you:Our success depends on the quality of our people. Thats why weve 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 familys 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 familys 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/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work weve done to become a more inclusive organisation. Were dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles.

ICON