Clinical Labeling Operations- Hybrid

Job Description

Job Description

Clinical Labeling Operations

Contract Opportunity

Rate: $56.80/hour

Location: Hybrid — candidates must reside within 50 miles of one of the locations below, listed in order of preference.

Thousand Oaks, CA

El Segundo, CA

Frederick, MD

Oceanside, CA

Foster City, CA

About the Role

We are seeking a Clinical Labeling Operations professional to coordinate the implementation of new clinical labeling across Regulatory Affairs, Quality Assurance, Supply Chain, and packaging sites worldwide. This role suits a detail-oriented professional with strong project coordination skills and a background in regulated pharmaceutical environments — someone comfortable navigating ambiguity and driving operational excellence initiatives from the ground up.

Essential Functions

• Coordinate new clinical labeling implementation across Regulatory Affairs Labeling, Quality Assurance Labeling, Supply Chain Labeling BPO, Project Managers, and multiple global packaging sites

• Create label content and map it to appropriate fields in Bartender

• Create Business Continuity Labels and map content to appropriate fields

• Review clinical final product label content and Bartender mapping to ensure accuracy against source documents and correct field placement

• Liaise with Regulatory Affairs Labeling colleagues to obtain accurate text, negotiate timelines, and confirm all requirements are met

• Lead operational excellence projects in areas without established precedent, executing effectively without prior direct experience

• Author SOPs, guidelines, and work instructions

• Collaborate cross-functionally with team members to meet departmental goals

• Complete labeling updates as assigned

Knowledge, Experience & Skills

• Strong ability to direct and coordinate cross-functional project work

• Excellent verbal, technical writing, and interpersonal communication skills

• Proficiency in Microsoft Office applications

• Working knowledge of FDA and cGMP standards and regulatory guidance documents

• Prior experience in pharmaceutical or another regulated industry

• Experience in clinical or commercial supply chain

• Familiarity with artwork/labeling production

• Bartender software experience a plus

• Education/Experience: BS/BA with 6+ years of relevant experience, or MS with 4+ years of relevant experience

ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.

Company Description

ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.