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

Job Summary:

Responsible for ensuring high quality execution of controlled procedural documentation management used for the conduct of business in clinical, medical, regulatory, safety and quality assurance organizations in compliance with regulations, laws, company policy and best practices.

Job Responsibilities: 

Controlled Procedural Documentation Management Responsibilities

Review Local Procedural Documentation:

• Reviews global procedural documents to understand updates/changes
• Conducts central review of local procedural documents to determine if they are in compliance with the global procedure (impact analysis)
• Communicates with local procedural document authors to provide feedback on the central review outcome
• Documents outcome of central review

Periodic Procedural Document Assessment:

• Coordinates automated notifications to authors of impacted local procedural documents that periodic assessments are due
• Completes quality review of periodic assessments and communicates with local procedural document authors to provide feedback
• Tracks the status assessment completion to ensure implementation and compliance
• Issues escalation notifications to local authors who are non-compliant with periodic assessment requirements

Quality Control of procedural documents:

• Performs quality control checks for global procedural documents, by following internal processes and established standards within agreed timelines, including prioritizing multiple tasks for timely completion
• Performs quality control checks of information in the process management relational database.
• Acts as a subject matter expert for established documentation standards and internal processes for consistency and compliance within a controlled regulatory environment, including providing accurate guidance and information to global procedural document authors

• Supports documentation life cycle within the Global Document Management System (GDMS) and process management relational database to maintain a state of inspection readiness.
• Provides other documentation management support including, but not limited to GDMS searches, metrics, technology initiatives and process improvement projects

Process Management Relational Database:

• Adds data/information into the process management relational database (i.e., a database that includes business process modeling and allows for management of controlled documents and associated information with an end user interface which provides the business access to internal colleagues, auditors, vendors, and regulatory authority inspectors) by collaborating with the SOP authors
• Completes data quality checks, periodic and ad hoc reviews of the process management relational database content including follow-up on resolution of potential content discrepancies.
• Supports the following: running of departmental metrics and other reporting activities; provides advice on process enhancements and continuous improvement, support resolution any questions about or issues arising from the Process portal, partake in user acceptance testing of new versions of the underlying portal management software or resolution of technical issues.

Qualifications:

• Minimum of a Bachelor’s degree or equivalent
• Demonstrated strong technical or digital skills in use of digital systems and new software
• Experience with design and documentation of pharmaceutical business processes (safety, regulatory, medical and/or clinical), or equivalent, such as experience of writing communications or training materials, intended for customers, or experience with process improvement projects and/or implementation of business process change management
• Experience of completing quality control review of pharmaceutical business process documentation (safety, regulatory, medical and/or clinical), or equivalent, such as quality control review of other types of documentation, training materials, presentations, communications or reports
• Experience of database maintenance, such as data entry, running reports and conducting data quality checks

History of achievement in a customer service role with demonstration of meeting customer needs and concerns

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.