Clinical Labeling Operations Specialist (100% Remote)

Dawar Consulting, Inc.; United States; Remote; USD 115,000 - 126,000; Full time

Job summary

Our client, a worldleader in biotechnology and gene therapy, seeks a Clinical Labeling Operations Specialist for a 100% remote, long-term contract role in the United States.

You will coordinate global labeling implementation with Regulatory Affairs, Quality, Supply Chain, PMs, and packaging sites; create and map label content within Bartender; review final product label mappings for accuracy; partner with Regulatory Affairs to obtain approved text and manage timelines; lead operational

Qualifications

• Bachelor’s degree with 6+ years of relevant experience, or Master’s degree with 4+ years of relevant experience.
• Experience in the pharmaceutical or other regulated industry.
• Experience with clinical or commercial supply chain operations.
• Familiarity with pharmaceutical artwork and labeling production.
• Knowledge of FDA regulations, cGMP standards, and regulatory guidance.
• Strong project coordination, communication, technical writing, and interpersonal skills.
• Proficiency with Microsoft Office.

Responsibilities

• Coordinate global clinical labeling implementation with Regulatory Affairs, Quality, Supply Chain, PMs, and packaging sites.
• Create and map label content within Bartender and develop Business Continuity Labels.
• Review final product label content and mapping for accuracy and alignment with source documents.
• Partner with Regulatory Affairs to obtain approved text, manage timelines, and ensure requirements are met.
• Lead operational excellence and process improvement projects.
• Author and update SOPs, guidelines, and work instructions.
• Support labeling updates and collaborate cross-functionally to meet departmental objectives.

Skills

Project coordination

Communication

Technical writing

Interpersonal skills

Microsoft Office

Education

Bachelor’s degree

Master’s degree

Tools

Bartender software

Job description

Our client, a worldleader in biotechnology and gene therapy, is looking for a ClinicalLabeling Operations Specialist (100% Remote).

Job Duration: LongTerm Contract (Possibility Of Extension) Pay Rate : $56.79/hr onW2 Company Benefits: Medical, Paid Sickleave, 401K

The Labeling Operations Specialist coordinates the implementation of new clinical labeling and labeling updates across Regulatory Affairs, Quality Assurance, Supply Chain, project teams, and packaging sites worldwide. This role ensures label content is accurately transferred, mapped, reviewed, and implemented in accordance with sourced documents, FDA requirements, cGMP standards, and applicable regulatory guidance.

Key Responsibilities

• Coordinate global clinical labeling implementation with Regulatory Affairs, Quality, Supply Chain, PMs, and packaging sites.
• Create and map label content within Bartender and develop Business Continuity Labels.
• Review final product label content and mapping for accuracy and alignment with source documents.
• Partner with Regulatory Affairs to obtain approved text, manage timelines, and ensure requirements are met.
• Lead operational excellence and process improvement projects.
• Author and update SOPs, guidelines, and work instructions.
• Support labeling updates and collaborate cross-functionally to meet departmental objectives.

Required Qualifications

• Bachelor’s degree with 6+ years of relevant experience , or Master’s degree with 4+ years of relevant experience .
• Experience in the pharmaceutical or other regulated industry .
• Experience with clinical or commercial supply chain operations.
• Familiarity with pharmaceutical artwork and labeling production.
• Knowledge of FDA regulations, cGMP standards, and regulatory guidance .
• Strong project coordination, communication, technical writing, and interpersonal skills.Proficiency with Microsoft Office.

Preferred

• Experience with Bartendersoftware and label content mapping.