Clinical Labeling Support Specialist

Job Summary

Responsibilities

Design, create, and transfer clinical study labels in alignment with global regulatory requirements and internal standards.

Perform rigorous proofreading and data entry on label proofs to ensure complete accuracy and regulatory compliance.

Cook up labeling documentation, approvals, and operational workflows with internal partners and global stakeholders.

Manage assigned clinical labels and studies independently while supporting cross-functional team projects.

Maintain professional, continuous communication across worldwide affiliates to support clinical trial timelines.

Qualifications

• Required: High School Diploma or equivalent.
• Proven experience in accurate data entry, document review, and record-keeping.
• Strong computer proficiency with the ability to quickly master new software systems.
• Exceptional attention to detail, time management, and organizational skills.
• Ability to work effectively in a regulated, compliance-driven environment.

Preferred

• Bachelor's degree in Science, English, Business, or a related field.
• Prior experience in biotech or pharmaceutical clinical operations.

Skills

• Safety Labeling Changes and Impact Assessment
• Labeling Compliance
• Investigational Product (IP) Labeling

Benefits

• Medical
• Dental
• Vision
• AD&D
• Life Insurance
• Short-term Disability
• 401K Plan

Pay

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.