Dawar Consulting, Inc. Verified

Clinical Labeling Operations Specialist (100% Remote)

RemoteRemoteContract$57–$57 /hrPosted 1 month agoHidden Gem · Himalayas

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Required skills

clinical labeling
labeling updates
Regulatory Affairs
Quality Assurance
Supply Chain
packaging sites
FDA requirements
cGMP standards
pharmaceutical
regulated industry

Nice to have

Bartender software
label content mapping
process improvement projects
SOPs
guidelines

Role summary

A world leader in biotechnology and gene therapy seeks a 100% remote Clinical Labeling Operations Specialist for a long-term contract. This role coordinates global clinical labeling implementation, ensuring accurate content transfer, mapping, review, and adherence to FDA requirements and cGMP standards. Responsibilities include creating and mapping label content in Bartender, reviewing final product labels, authoring SOPs, and leading process improvement projects. Requires a Bachelor's degree with 6+ years of relevant experience or a Master's with 4+ years, preferably in the pharmaceutical industry with supply chain operations experience. Familiarity with pharmaceutical artwork, labeling production, FDA regulations, and cGMP is essential. Proficiency in Microsoft Office and strong project coordination, technical writing, and communication skills are necessary. Experience with Bartender software and label content mapping is preferred.

Our client, a worldleader in biotechnology and gene therapy, is looking for anClinicalLabeling 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 OperationsSpecialist coordinates the implementation of new clinical labeling and labelingupdates across Regulatory Affairs, Quality Assurance, Supply Chain, projectteams, and packaging sites worldwide. This role ensures label content is accuratelytransferred, mapped, reviewed, and implemented in accordance with sourcedocuments, FDA requirements, cGMP standards, and applicable regulatoryguidance.

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.

If interested, pleasesend us your updated resume at

Originally posted on Himalayas

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