Clinical Labeling Operations Specialist (100% Remote)
About this role
Our client, a worldleader in biotechnology and gene therapy, is looking for anClinicalLabeling Operations Specialist.
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
