Labeling Project Coordinator

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

Location Requirement: Candidates must be within 50 miles of one of the preferred locations

Job Description:

• Responsible for the coordination of new clinical labeling implementation with Regulatory Affairs Labeling, Quality Assurance Labeling, Supply Chaing Labeling BPO, PM’s and multiple packaging sites worldwide.
• Creates labels content and maps content to the appropriate fields in Bartender.
• Creates Business Continuity Labels and maps contents to the appropriate fields.
• Reviews clinical final product label content and Bartender mapping to ensure all content matches source documents and text is mapped to the appropriate fields.
• Liaises with Regulatory Affairs Labeling colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met.
• Manages the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience.
• Authors standard operating procedures, guidelines and work instructions.
• Collaborates with team members to meet departmental goals and objectives.
• Completes labeling updates as assigned.

Knowledge, Experience and Skills:

• 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.
• Familiarity with Bartender software is bonus.
• 6+ years of relevant experience and a BS or BA or 4+ years of relevant experience and a MS.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”