<p>Overview</p> <p>As a Label Project Coordinator you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.</p> <p>Responsibilities</p> <p>What you will be doing:</p> <ul> <li>Read, comprehend, and translate clinical trial protocols/packaging specifications into clinical label generation software. </li><li>Individual will design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the label systems. </li><li>Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs. </li><li>Perform investigations, update SOPs, manage Change Records, and implement new equipment/processes. </li><li>Ensures all clinical supplies and associated documentation are processed according to GMPs/GDPs and appropriate Merck safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies. </li><li>May be responsible for any or all of the following: </li><li>Coordination and completion of translation requests. </li><li>Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address question, revise translations, update regulatory requirements etc. </li><li>Maintain label translations library. </li><li>Interpret clinical study design and Clinical Supply Strategy (CSS). </li><li>Design and verify label models. </li><li>Coordinate MLBL manufacturing at vendors. </li><li>Provide detailed analysis of issues and collaborate for creative problem solving. </li><li>Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders. </li><li>May represent Label Room Production on internal or cross-functional teams. Will undertake and lead specific projects within the group on as needed basis. </li><li>Participate as necessary in complaint and deviation investigations with a focus on true root cause and creation of appropriate Corrective and Preventative actions (CAPA). Drive CAPA to closure. </li><li>Train Label Project Coordinator Level I or Level II team members and remain proficient in appropriate systems and software. </li><li>Responsible for the physical facility and good housekeeping practices within their area. </li><li>Utilize project management skills to lead and implement new process, technology, and equipment implementation. </li><li>Update Standard Operations Procedures and Change Records. </li></ul> <p>Qualifications</p> <ul> <li>BS/BA with 5+ years of experience or 8+ years of experience without degree. </li><li>Working knowledge of Packaging Operations and related work centers. </li><li>Proactive approach to work, identifying potential issues and bringing them to the attention of appropriate personnel for resolution. </li><li>Strong attention to detail. </li><li>Strong verbal and written communication skills. </li><li>Strong organizational skills, ability to prioritize and ability to mutli-task. </li><li>Knowledge or general computer skills (i.e. MS Word, Excel, PowerPoint). </li><li>Project Management skills </li><li>Technical writing skills. </li></ul> <p>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:</p> <ul> <li>Various annual leave entitlements </li><li>A range of health insurance offerings to suit you and your family's needs </li><li>Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead </li><li>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 </li><li>Life assurance </li><li>Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others </li></ul> <p>Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt 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-accommodationsInterested 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.</p>