Job Abstract

Label Project Coordinator Level- II

Summary: 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 Merck label systems. Individual will interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
Primary activities

• Ensures all clinical supplies and associated documentation are processed according to GMPs/GDP’s and appropriate Merck safety requirements to meet exacting standards defined by Merck, 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 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)

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