Shirley Ladler-Dennis Email and Phone Number

Overseeing and joining together essential labeling tasks and activities for the start-to-release of drug product specific to cancer and cell therapy treatment. Working with a team of labeling coordinators, regulatory specialists, engineers, and graphic designers to provide management and support throughout the life cycle of label launches, creation, and revisions.• Collaborate with departments, including Regulatory Affairs, Packaging Engineering and QA to confirm country requirements and site set up of labeling content, files, and documentation. • Engage with global cross-functional teams to scope and execute projects per schedule. Including supporting Change Controls, change assessments and approvals.• Work to facilitate label reviews, including inspections and proofing of labeling artworks.

At BioMarin, I advanced to the role of Product Artworker Owner (PAO), Senior Specialist. The PAO is responsible for the start-to-release project management and labeling updates of drug products and devices. Actively working with Regulatory requirements, Packaging Engineering specifications, Supply Chain coordination, QA, and manufacturing sites. • Managed the delivery of twelve labeling projects, in three days, for an urgent market launch. Met deadline to release product, saving the company thousands of dollars in additional charges.• Leading project planning meetings for artwork labeling. Collaborating with Regulatory Affairs, Packaging Engineering, Supply Chain, and QA. Together we planned and aligned to ensure that products were released to market accurately and on time.• Not only managed a team of coordinators but also created labeling projects in the company’s Artwork Management System (AMS), enabling more project completions.• Background in design assisted in preventing delays with artwork projects. Having the knowledge to see design issues before they became errors, saved time, and enabled teams to meet artwork release dates on and sometimes ahead of time.• Worked regularly with GDP, validation, and change control processes, enabling actions from groups to be accurately captured for auditing and historical records.• Familiarity with Regulatory documentation such as MAHs and Packaging Engineering dielines and specifications, allowed me to run better organized, targeted, and successful meetings.

As a Global Labeling Specialist, my role was to manage and complete labeling artworks for cartons, leaflets and similar in the Artwork Management System. I was also responsible for the completion of the projects’ correlating change control records. Working to ensure labeling progressed, I met with Regulatory Affairs, Packaging Engineering, Quality Assurance, and others. Discussing and resolving issues with documentation, dielines, manufacturing or related, that delayed projects.• Achieved a 100% error free rate for labeling completed in a quarter.• Successfully managed labeling artworks in the Artwork Management System, resulting in more accurate project starts and faster completions.• Brought knowledge and expertise to product meetings, providing clarity on artwork readiness and content questions. This was particularly important when projects required specific, subject matter input for acceleration of pack dates. • Initiated and managed Change Control records providing labeling detail and history necessary for auditing and compliance purposes

As the Creative Manager at Nelson Connects, I managed the design needs of the Marketing department and company. This included leading the creation of graphic, print and media projects, PowerPoint presentations, website maintenance, and campaign launches. While working with internal/external departments, the ability to collaborate successfully with other managers was essential.• Created and designed over eight years’ worth of Nelson Staffing Advisor booklets. Business generated by these represented a sizeable percentage of the company’s annual revenue. • Integral in the company’s identity rebrand. Redesigning the corporate print media and collaborating with a partner company to redesign the corporate online presence. The effort increased traffic to the site and brought in more candidates and clients.

My job entailed creating overnight line ads for the business section of the paper. Working from a minimal customer description and concept, I created imagery for ads; from the limited content provided. This required being innovative and fast, while maintaining accuracy.