Senior Clinical Labeling Operations Lead

TekWissen ®; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

TekWissen Group, in Thousand Oaks, is seeking an experienced labeling coordinator for a biotech client. The role focuses on clinical labeling implementation, mapping content in Bartender, and ensuring regulatory compliance across global sites.

Ideal candidates have 6+ years of related experience or 4+ years with an MS, with solid knowledge of FDA/cGMP guidance and experience in pharmaceutical labeling workflows. Strong writing and coordination skills are essential.

Qualifications

• 6+ years of relevant experience or 4+ years with MS in a related field.
• Knowledge of FDA and cGMP standards and regulatory guidance documents.
• Prior experience in pharmaceutical or other regulated industry required.
• Prior experience in clinical or commercial supply chain.
• Familiarity with artwork/labeling production and Bartender is a plus.

Responsibilities

• Coordinate new clinical labeling implementation with Regulatory Affairs and labeling teams.
• Create labels content and map to fields in Bartender.
• Review final product label content and ensure mapping accuracy.
• Liaise with Regulatory Affairs labeling colleagues to meet timelines and requirements.
• Author SOPs, guidelines, and work instructions.
• Collaborate with team to meet departmental goals and complete labeling updates.

Skills

Project coordination

Verbal communication

Technical writing

Microsoft Office

Regulatory knowledge

Education

BS/BA in Life Sciences

MS in Life Sciences

Tools

Bartender software

Job description

TekWissen Group, in Thousand Oaks, is seeking an experienced labeling coordinator for a biotech client. The role focuses on clinical labeling implementation, mapping content in Bartender, and ensuring regulatory compliance across global sites.

Ideal candidates have 6+ years of related experience or 4+ years with an MS, with solid knowledge of FDA/cGMP guidance and experience in pharmaceutical labeling workflows. Strong writing and coordination skills are essential.