Clinical Labeling Operations - Onsite

AGW; Thousand Oaks (CA); On-site; USD 45,000 - 76,000; Full time

Benefits offered by this job

Medical

Vision

Sick Pay

Job summary

Aptask Global Workforce (AGW) is seeking a Clinical Labeling Operations professional for an onsite, 12+ month contract in Thousand Oaks, CA. The role coordinates new labeling implementation with Regulatory Affairs, QA and Supply Chain across global packaging sites, ensuring content accuracy and regulatory compliance.

Responsibilities include label content creation, Bartender mapping, SOP drafting, and cross‑functional collaboration to meet project timelines.

Qualifications

• 6+ years of relevant experience or 4+ years with a MS degree.
• Experience directing and coordinating complex project work.
• Strong written and verbal communication and interpersonal skills.
• Proficiency with Microsoft Office applications.
• Knowledge of FDA and cGMP standards and regulatory guidance documents.
• Experience in pharmaceutical or other regulated environments.

Responsibilities

• Coordinate new clinical labeling implementations across multiple sites globally.
• Create label content and map to Bartender fields; review for accuracy.
• Map and author Business Continuity Labels and ensure proper content.
• Ensure labeling content aligns with source documents and regulatory requirements.
• Prepare SOPs, guidelines and work instructions; support cross‑functional goals.

Skills

Project coordination

Verbal communication

Technical writing

MS Office

Regulatory knowledge

Education

BS/BA

MS

Tools

Bartender

Job description

Clinical Labeling Operations - Onsite #26-10483

Thousand Oaks, CA Onsite Contract Starts 10/26/2026 Ends 10/25/2027

Aptask Global Workforce (AGW) is seeking a Clinical Labeling Operations for an Onsite position with a Global Biotechnology Company located in Thousand Oaks, CA; El Segundo, CA; Frederick, MD; Oceanside, CA; or Foster City, CA. This is a 12+ month contract opportunity.

This role is responsible for coordinating the implementation of new clinical labeling in collaboration with Regulatory Affairs, Quality Assurance, and Supply Chain teams across multiple global packaging sites. The successful candidate will create and review label content, manage project timelines, and ensure all activities adhere to FDA and cGMP standards within a regulated pharmaceutical environment.

Responsibilities:

• Coordinate new clinical labeling implementation with Regulatory Affairs Labeling, Quality Assurance Labeling, Supply Chain Labeling BPO, PMs and multiple packaging sites worldwide
• Create label content and map content to the appropriate fields in Bartender
• Create Business Continuity Labels and map contents to the appropriate fields
• Review clinical final product label content and Bartender mapping to ensure all content matches source documents and text is mapped to the appropriate fields
• Liaise with Regulatory Affairs Labeling colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met
• Manage the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience
• Author standard operating procedures, guidelines and work instructions
• Collaborate with team members to meet departmental goals and objectives
• Complete labeling updates as assigned

Requirements:

• 6+ years of relevant experience and a BS or BA or 4+ years of relevant experience and a MS
• Highly capable at directing and coordinating project work
• Strong verbal, technical writing and interpersonal skills
• Proficient in Microsoft Office applications
• Knowledge of FDA and cGMP standards as well as regulatory guidance documents
• Prior experience in pharmaceutical or other regulated industry is required
• Prior experience in clinical or commercial supply chain
• Familiarity with artwork/labeling production

Desired skills:

• Familiarity with Bartender software is a bonus

Pay range: up to $54.74 per hour

Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

Benefits of working with ApTask Global Workforce include:

• Medical
• Vision
• Sick Pay (for applicable states/municipalities)

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran. #INDAGW