Clinical Labeling Support Specialist

Location: Waukegan Road, North Chicago, IL 60064

Work Schedule
: Hybrid: Onsite Tuesday, Wednesday, Thursday | Remote Monday, Friday - Non-negotiable)

Duration: 6-12 months (Based on performance and business needs)

Work Environment: Highly Regulated / GMP Environment

The Clinical Labeling Support Specialist will support the Clinical Labeling Team in creating, designing, reviewing, and proofreading clinical study labels for clinical supplies in a highly regulated Good Manufacturing Practice (GMP) environment.

A primary focus of this role will be assisting the team with a major system transition by migrating label information between systems. The ideal candidate must possess exceptional attention to detail, strong computer proficiency, and high-accuracy data entry skills. Direct clinical labeling experience is a bonus, not required, as training will be provided; however, candidates must demonstrate the ability to learn new software applications quickly and work independently in a fast-paced environment.

• Education: High School Diploma or Equivalent required;
  Associate's or Bachelor's degree in Science, English, Business, or a related field preferred. (
  
  Note:
  
  Candidates with a Master's degree will be considered, but must be aligned with a foundational, hands-on role).
• Data Entry & Accuracy: Proven experience performing high-volume data entry with outstanding precision and zero tolerance for error.
• Computer Proficiency: Strong overall technical/computer skills with a demonstrated ability to learn new software, systems, and tools rapidly.
• Regulated Environment
  
  Experience:
  
  Background working within a GMP (Good Manufacturing Practice) or highly regulated environment, following strict SOPs and compliance standards.
• Technical Software: Proficiency in Microsoft Excel and tracking/intake tools like Smartsheet
  .
• Design Tools: Familiarity with label design software or non-Adobe graphic design software is a plus.
• Analytical Mindset: Prior experience reviewing analytical documentation, source documents, or clinical trial protocols.
• Relevant Roles: Experience as a Clinical Research Coordinator, Document Control Specialist, Quality/Regulatory Documentation Support, or Data Entry Specialist in pharma/biotech.

• Data Migration & System Support: Assist with transitioning label data from a legacy system to a new labeling system with a high level of precision.
• Label Proofreading & Quality Control: Perform meticulous proofreading of clinical label proofs to ensure 100% accuracy, including characters, multi-country/multi-language text, and regulatory compliance.
• Label Design & Creation: Design and create clinical labels according to established specifications, protocols, and regulatory requirements.
• Documentation & Process Execution: Follow Standard Operating Procedures (SOPs), interpret clinical protocols, and utilize source/analytical documentation to build accurate label content.
• Workflow & Coordination: Manage and track assigned label tasks using tools like Smartsheet and Microsoft Excel, ensuring no mix-up of information across multiple concurrent projects (high-volume workload).
• Communication: Coordinate labeling activities and documentation with global affiliates, project managers, and internal stakeholders.

• Attention to Detail: Absolute accuracy in reviewing characters, symbols, and text across foreign languages.
• Time Management & Multitasking: Ability to handle a high workload across multiple active studies without mixing up project details.
• Adaptability & Fast Learner: Quick to absorb training on complex software systems and operate independently in the short term.
• Reliability & Communication: Clear written/verbal communication skills and a strong sense of accountability in a collaborative team setting.