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Vita Global Sciences, a Kelly Company · 8 hours ago

Label Project Coordinator II

West Point, PA

Contract

Onsite

Mid Level

3+ years exp

Vita Global Sciences, a Kelly Company, is seeking a Label Project Coordinator II for a long-term engagement with a Global Pharmaceutical client. This role involves identifying future tasks, engaging stakeholders, and translating clinical trial protocols into clinical label generation software.

AnalyticsData VisualizationInformation Technology

Responsibilities

Identify future tasks and engage with stakeholders for next steps

Collaborate with team members to ensure operational success

Maintain accurate documentation related to technical 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 FDA and EU or other international regulatory agencies

May be responsible for any or all the following:

Coordination of translation requests

Generation of clinical label content

Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address questions, 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 and clinical labels

Provide detailed analysis of issues and collaborate for creative problem solving

Liaise with Clinical Supply Project Managers, 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

Qualification

Label generation softwarePackaging OperationsCGMP complianceClinical trial protocolsMS Office SuiteOrganizational skillsProblem-solving skillsInterpersonal skills