Project Coordinator With Pharmaceutical/Clinical

PROJECT COORDINATOR WITH PHARMACEUTICAL/CLINICAL WEST POINT, PA Onsite. Project Description:

• 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 company's label systems.
• Individual will interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
• Ensures all clinical supplies and associated documentation are processed according to GMPs/GDP's and appropriate company safety requirements to meet exacting standards defined by the company, 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 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 and remain proficient in appropriate systems and software.
• Responsible for the physical facility and good housekeeping practices within their area.

• 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).