Kelly Science, Engineering, Technology & Telecom · 2 days ago
Label Project Coordinator II
Montgomery County, PA
Full-time
Onsite
Mid Level
3+ years expKelly Science, Engineering, Technology & Telecom is seeking a Label Project Coordinator II who will be responsible for engaging with stakeholders and managing clinical label generation processes. This role involves interpreting clinical trial protocols and ensuring compliance with regulatory standards while collaborating with various teams to maintain operational success.
Staffing & Recruiting
Hiring Manager
Lea Lolley
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
Preferred
Bachelor's degree preferred; candidates with relevant experience may be considered
3+ years of experience in a related field; candidates without a degree should have 6+ years of relevant experience
Working knowledge of Packaging Operations and related work centers
Knowledge of general computer skills (i.e., MS Word, Excel, PowerPoint)
Strong organizational and detail-oriented skills
Problem-solving and troubleshooting abilities
Interpersonal skills, including verbal and written communication
Understanding supply chain impacts and operational efficiency
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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