Coordinate global clinical labeling implementation, map and validate label content in Bartender, partner with Regulatory Affairs and quality teams, author SOPs and process improvements, and support labeling updates to ensure compliance with FDA, cGMP, and company requirements.
Our client, a world
leader in biotechnology and gene therapy, is looking for an Clinical
Labeling Operations Specialist.
Job Duration: Long
Term Contract (Possibility Of Extension)
Pay Rate : $56.79/hr on
W2
Company Benefits: Medical, Paid Sick
leave, 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 source
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 Bartender
software and label content mapping.
If interested, please
send us your updated resume at
[email protected]/[email protected]
Similar Jobs
Big Data • Marketing Tech • Sales • Software • Analytics • Big Data Analytics
Leads billing and revenue accounting, including revenue recognition under ASC 606, invoicing, reconciliations, reporting, sales rebates, client onboarding, and month-end close. Manages and develops the billing team, resolves customer escalations, coordinates cross-functional onboarding with Sales, Legal, People & Culture, and IT, and improves NetSuite billing and reporting workflows. This is a client-facing hybrid role requiring four days weekly at the Westlake Village headquarters.
Top Skills:
NetSuite
Financial Services
Lead the design, development, deployment, and operation of agentic AI and LLM-powered products and platform services. Establish engineering standards, build evaluation and observability capabilities, implement safety and governance controls, and mentor engineers. Partner with product, security, risk, data, and engineering stakeholders to define roadmaps, success metrics, and scalable production outcomes. The role also contributes to documentation, reference implementations, and enablement for responsible enterprise AI adoption.
Top Skills:
Agentic AiAmazon Web Services (Aws)Continuous DeliveryContinuous IntegrationDatabricksDockerEmbedding PipelinesGoogle AdkKubernetesLanggraphLarge Language Models (Llms)LlamaindexPrompt EngineeringPythonRetrieval-Augmented Generation (Rag)Vector Databases
5 Hours Ago
Financial Services
Provide comprehensive financial planning and advice to individuals and families, build and manage a book of business, acquire and deepen client relationships, deliver personalized investment solutions, educate clients on digital channels, and collaborate with Chase partners to meet clients’ broader financial needs.
What you need to know about the Los Angeles Tech Scene
Los Angeles is a global leader in entertainment, so it’s no surprise that many of the biggest players in streaming, digital media and game development call the city home. But the city boasts plenty of non-entertainment innovation as well, with tech companies spanning verticals like AI, fintech, e-commerce and biotech. With major universities like Caltech, UCLA, USC and the nearby UC Irvine, the city has a steady supply of top-flight tech and engineering talent — not counting the graduates flocking to Los Angeles from across the world to enjoy its beaches, culture and year-round temperate climate.
Key Facts About Los Angeles Tech
- Number of Tech Workers: 375,800; 5.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Snap, Netflix, SpaceX, Disney, Google
- Key Industries: Artificial intelligence, adtech, media, software, game development
- Funding Landscape: $11.6 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Strong Ventures, Fifth Wall, Upfront Ventures, Mucker Capital, Kittyhawk Ventures
- Research Centers and Universities: California Institute of Technology, UCLA, University of Southern California, UC Irvine, Pepperdine, California Institute for Immunology and Immunotherapy, Center for Quantum Science and Engineering
