Do you want to be responsible for performing review, coding, and entry of audit report findings, assists with facilitation of Corrective and Preventative Actions (CAPAs), and participates in GCP related projects?  Participates in facilitating or co-audits as experience increases and proficiency is demonstrated.

Hybrid role - 3 days weekly onsite in Rahway, NJ office. 2 days remote. 

What Will you Be Doing?

• Familiar with the regulations and requirements of Good Manufacturing Practices in the Pharmaceutical Industry.
• Execute activities, in accordance with departmental SOPs, guidance documents, job aids, etc.
• Facilitate, support and coordinate the timely review of quality documentation required in support of Quality departmental activities. Facilitate the resolution of any quality issues as needed, in collaboration with key stakeholders.
• Proficient with the use of Microsoft Office Applications (e.g., Excel, WORD, and PowerPoint), and creation of flowcharts. Ability to write Excel formulas including lookups, text comparison and logical formulas. Familiarity with Microsoft Word Quick parts.
• Support, monitor and maintain business tools- SharePoint, Power BI, Spotfire, and Power Apps.
• Responsible for monitoring incoming mail/notifications from Third Parties.
• Compile metrics of key performance indicators, track and report out.
• Interested in applying Artificial Intelligence to simplify work processes, in close collaboration with key stakeholders.
• Support the workflow of User Acceptance Testing of business tool applications, as needed.

Education and Work Experience:

• An undergraduate degree or its international equivalent from an accredited institution is Required.
• Preferably a Degree in the health-sciences or computer sciences

Knowledge, Skills, and Abilities:

• Experience in clinical research organization is preferred
• Basic understanding of ICH GCP, FDA CFR, and EU directive
• Read, write and speak fluent English; fluent in host country language required.
• Working knowledge of the Clinical Trial Supply process
• Working knowledge of project team structure and processes
• Proactive approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution.
• Knowledge of project management and Clinical customer relationship building
• Knowledge of the ‘Customers’ team structures and processes
• Excellent verbal and written communication skills
• Ability to influence others
• Ability to multi-tasks
• Strong organizational skills
• Experience in conflict resolution and negotiation skills
• Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint, MS Project and Access

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, 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 we’ve done to become a more inclusive organisation. 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, 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-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.