Label Project Senior Coordinator
4 months ago
Primary activities
- 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 client, the FDA and EU or other international regulatory agencies.
- 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 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.
- Train Label Project Coordinator Level I team members and remain proficient in appropriate systems and software
- Responsible for the physical facility and good housekeeping practices within their area.
**Requirements**:
BS/BA or appropriate combination of education and relevant practical experience
Working knowledge of Packaging Operations and related work centers
Proactive approach to work, identifying potential issues and bringing them to the attention of appropriate personnel for resolution
Strong attention to detail
Strong verbal and written communication skills
Strong organizational skills, ability to prioritize and ability to multi-task
Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint).
**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.
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