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.

Hybrid Role: 3 days weekly onsite. 2 days remote.

Location: Basking Ridge, NJ

What you will be doing:

The Sr. Clinical Supply Operations Specialist provides support to the Clinical Drug Supply & Logistics group in the Investigational Product (IP) distribution process, ancillary supplies process and comparator procurement process, for one or more molecules across multiple Therapeutic areas; supporting highly complex studies as well as long-term departmental and cross-functional projects and on-going continuous improvement initiatives. This may include leading short-term projects. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines and Regeneron Standard Operating Procedures (SOPs) / Work Practice Documents (WPDs). This role applies to internally sourced studies and/or CRO/Partnered studies.

What you will be doing:

• IP Supply & Inventory Planning:
• Accountability, Reconciliation, Returns & Destruction (ARRD)
• Internal System Management including lot creation, batch status, and inventory maintenance
• Assessment and Oversight activities (risks, stocking levels, trends)
• IP Shipments
• System and Non-system generated Shipments
• Depot transfers o Temperature Excursion Management
• IP Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)
• Expected Document List (EDL) creation
• eTMF Document Management per regulatory requirements
• QA/QP Release Management
• Pack-and-label kit and sequence reconciliation
• Inspection Readiness activities
• IRT management activities including IRT Alert management and UAT activities
• Suspected Serious Non-Compliance support
• Ancillary Supply & Inventory Planning/Management
• Procurement support (Includes Work Order Management)
• Vendor RFI support o Supply Planning & Inventory Management
• Ancillary Supply Plan creation
• Shipping & Logistics (Includes International Logistics requirements for Ancillaries)
• Shipping & logistics activities
• Temperature Excursions
• Lot management
• eTMF activities
• ARRD activities
• Comparator Planning & Management
• Market Intelligence Reports
• Quote/PO/Requisition Process Support
• IMN Creation
• Document Storage
• Temperature Excursions
• Financial Forecasting, Budgeting & Planning
• Forecast Submissions
• Order Ticket Entry
• Demand Updates

You are:

• BS/BA degree in a related field. Minimum of 3+ years of experience in the following fields:
• Clinical Supplies
• QA/Regulatory
• Precision Medicine
• Supply Chain
• Manufacturing
• Or equivalent research/commercial biopharma experience
• Hybrid Role: The person in this role would need to be onsite 3 days a week in Basking Ridge, NJ to start for training for 2-3 months.  Once fully trained will reduce to 2 days required weekly onsite---Local candidates to the NJ location only will be considered. 

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.