The team member will be responsible to read, comprehend, and translate clinical trial protocols /packaging specifications into clinical label generation software. Individual will design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the label systems. Individual will interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
This position is located in West Point, PA.
5 days weekly onsite - Monday - Friday
What you will be doing:
- Ensures all clinical supplies and associated documentation are processed according to GMPs/GDP’s and appropriate safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies.
- Coordination of Translation Requests o Generation of Clinical Label Proofs with CLPG
- Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address question, revise translations, update regulatory requirements, etc.
- Maintain Label Translations library
- Interpret clinical study design and Clinical Supply Strategy (CSS)
- Design and verify label models
- Coordinate MLBL manufacturing at vendors
- Perform visual inspection and accountability for label proofs, clinical labels and RCE’s
- Provide detailed analysis of issues and collaborate for creative problem solving
- Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders.
- May represent Clinical Packaging on internal or cross-functional teams. Will undertake and lead specific projects within the group on as needed basis
- Participate as necessary in complaint and deviation investigations with a focus on true root cause, and creation of appropriate Corrective and Preventative actions (CAPA's). Drive CAPA's to closure.
- Assist in training new team members and remain proficient in appropriate systems and software
- Responsible for the physical facility and good housekeeping practices within their area.
You are:
Bachelor’s degree preferred Required Experience/Skills: • 3+ years (with degree) • 6+ years (without degree) • Organization, detail oriented, equipment operation skills, equipment repair, problem solving, troubleshooting, interpersonal skills incl. verbal and written, multitasking, collaboration • Able to connect the dots with task and identify future tasks to be done or whom to engage on next steps; understands supply chain and impact to success or failure of an action up and down the supply chain
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.