Clinical Labeling Operations Contract:

1

Year Location:

Preferred candidates within 50 miles of: Thousand Oaks, CA El Segundo, CA Frederick, MD Oceanside, CA Foster City, CA Position Summary We are seeking an experienced Clinical Labeling Operations professional to coordinate clinical labeling implementation activities across Regulatory Affairs, Quality Assurance, Supply Chain Labeling, Project Management, and global packaging sites. Key Responsibilities Coordinate new clinical labeling implementation with Regulatory Affairs Labeling, Quality Assurance Labeling, Supply Chain Labeling BPOs, Project Managers, and multiple packaging sites worldwide. Create label content and map content to the appropriate fields in Bartender . Create Business Continuity Labels and map content to the appropriate fields. Review final clinical product label content and Bartender mapping to ensure all content matches source documents and is mapped accurately. Partner with Regulatory Affairs Labeling colleagues to obtain correct text, negotiate timelines, and ensure all requirements are met. Manage operational excellence projects where precedents may not exist and outcomes require developing and executing new approaches. Author and maintain SOPs, guidelines, and work instructions . Collaborate with cross-functional team members to achieve departmental goals and objectives. Complete labeling updates and other assigned projects. Required Qualifications 6+ years of relevant experience with a Bachelor's degree , OR 4+ years of relevant experience with a Master's degree . Prior experience in the pharmaceutical or other regulated industry . Experience with clinical or commercial supply chain . Familiarity with artwork and labeling production . Knowledge of FDA and cGMP standards and applicable regulatory guidance documents. Strong project coordination and organizational skills. Excellent verbal, technical writing, and interpersonal communication skills. Proficiency with Microsoft Office applications . Preferred Qualifications Experience with Bartender software . Experience with clinical labeling and packaging operations. Experience coordinating labeling activities across global packaging sites. Experience developing SOPs, guidelines, and work instructions. Key Skills Clinical Labeling | Labeling Operations | Pharmaceutical | Supply Chain | Artwork | Packaging | Regulatory Affairs | FDA | cGMP | Bartender | SOPs | Project Coordination | Microsoft Office SNR8 #IND2

Pay:

$45.00 - $53.00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance Application Question(s):

• Are you a US Citizen or GCH? If on Visa please mention the Visa Status
• Are you ready for background check and drug screen in accordance with the local law and regulations?
• Please confirm your email address and contact number?
• Cube Hub payroll is "Bi-Weekly, we pay every-other-Friday. Are you Comfortable with Bi-Weekly payroll policy?
• What is your Expected Pay Range?
• What is a good time to contact you?
• Are you ok with following Shift (First Shift) Do you have 6+ years of relevant experience in pharmaceutical or another regulated industry, with a BS/BA?

Do you have experience with clinical/commercial supply chain and pharmaceutical labeling or artwork production? Do you have experience with Bartender labeling software or similar label-management systems?

Work Location:

In person