Job Information
ICON Clinical Research Label Project Coordinator in United States
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.
Location: West Point, PA. Monday - Friday. 5 days weekly on-site.
Labeling, bottling and/or Translation of labels experience highly preferred.
Pharma/CRO experience highly preferred but other industry experience will be considered.
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 team, the FDA and EU or other international regulatory agencies.
May be responsible for any or all of the following:
Coordination of Translation Requests
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 vendor
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.
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
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.
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.