Clinical Labeling Project Lead (Regulatory)

Mindlance; Thousand Oaks (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Mindlance seeks an experienced labeling professional to coordinate the implementation of clinical labeling with Regulatory Affairs, QA labeling, and packaging sites worldwide. You will create label content, map fields in Bartender, and ensure accuracy against source documents.

Responsibilities include liaising with Regulatory Affairs, driving operational excellence projects without precedent, writing SOPs, and delivering labeling updates on schedule. 5+ years in pharma labeling preferred.

Qualifications

• 6+ years of relevant experience with a BS/BA, or 4+ years with an MS.
• Experience coordinating labeling projects across Regulatory, QA and packaging sites.
• Experience with artwork/labeling production workflows.
• Knowledge of FDA/regulatory requirements.

Responsibilities

• Coordinate new clinical labeling implementation with Regulatory Affairs and QA labels teams.
• Create label content and map fields in Bartender.
• Develop Business Continuity Labels and map contents.
• Review final label content and Bartender mappings against source docs.
• Liaise with Regulatory Affairs Labeling to obtain text and timelines.
• Drive operational excellence projects without prior precedents.
• Draft standard operating procedures, guidelines and work instructions.
• Collaborate with team to meet departmental goals.
• Complete labeling updates as assigned.

Skills

Project coordination

Regulatory labeling knowledge

FDA & cGMP familiarity

Excellent written communication

Supply chain coordination

Education

BS/BA in Life Sciences or Chemistry

MS in related field

Tools

Bartender

Microsoft Office

Job description

Mindlance seeks an experienced labeling professional to coordinate the implementation of clinical labeling with Regulatory Affairs, QA labeling, and packaging sites worldwide. You will create label content, map fields in Bartender, and ensure accuracy against source documents.

Responsibilities include liaising with Regulatory Affairs, driving operational excellence projects without precedent, writing SOPs, and delivering labeling updates on schedule. 5+ years in pharma labeling preferred.