Clinical Document Specialist

As a Clinical Document Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

This role focuses on quality control of regulatory submission documents and is dedicated to global pharma company. This role involves tasks related to formatting and document/project management of regulatory documents.  

What you will be doing:

• Works in the global team to provide number and technical quality control (QC) to CSP, CSR and submission documents, and ensures the supporting documents are filed for inspection or audit
• Works in the global team to compile CSR appendices, and coordinates the CSR publishing
• Uses project management skills to track and to timely complete the assigned tasks
• Supports the technical platform of MW, including but not limited to the support of document management system (Veeva), document review/comment system, maintaining the related templates, EndNote libraries and related SharePoint sites
• Achieve high quality results with the assigned tasks with little or no supervision

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You are:

• At least one year of Clinical Document Specialist or Regulatory Documents or equivalent experience, knowledge of protocol and CSR is required 
• Bachelor’s degree. 
• Must demonstrate strong English and communication skills, both written and verbal.
• Must be able to deliver high quality of job related tasks independently.
• Experience working in a global environment is preferred.
• Experience with document management is preferred.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re 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, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.