Please note: this position is NOT a graphic design role, it is more of a project coordination role.

Job Title: Clinical Labeling Operations

Location: Full list of preferred locations (ranked in order of preference) is within 50 miles of:

• Thousand Oaks, CA
• El Segundo, CA
• Frederick, MD
• Oceanside, CA
• Foster City, CA

Essential Functions:

• 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.