- Responsible for establishing a robust , effective and efficient process for managing changes in Novocure products labels- Identify solutions for the Clinical, NPI and Sustaining labeling change request requirements- Responsible for implementing and maintaining the effectiveness of the quality system bydelivering the “perfect label” through an effective and efficient label change management process. - Scope of label changes includes Regulatory Affairs for labeling submissions, Novocure OCs, third party manufacturers and third party partners- Interact with key stakeholders such as Regulatory Affairs and NPI, as needed, to successfully execute label change requests and proofreading for the verification of developed label copy against the source documents- Evaluate the impact of a label change on associated labels and manufacturing operations- Ensure completeness, accuracy, and control of changes in labeling including maintenance oflabeling related specifications and documentation associated with these specifications- Work closely with NPI in the creation of label artwork, mock ups utilized for regulatorysubmissions, and assist commercial/clinical , as required, in the development of label designs forpackaging and labeling commodities- Lead sections of process improvement projects and propose solutions.

• Performs Internal Audits and leads effort to resolve any findings.• Supports the CAPA system• Coordinates the Non-Conformance System• Manages all registration and listing for license renewal• Submits technical dossier’s to Notified Body portal• Updates the Essential Requirement Checklists and Declaration of Conformity• Reviews labeling changes or new labeling for new product• Contributes to Investigation Team• Supports all Quality System activities to maintain regulatory requirements• Keep current with all internal procedures, as well as changes in all relevant regulatory guidelines and subsequent standards• MDR Labeling Compliance

• Evaluate problems that may occur in Label Release, Purchasing and Manufacturing. Take action as necessary to correct and solve problems; involve and assist management in investigation and resolution of problems as needed.• Determine and drive the labeling regulatory strategy for the product labeling and instructions for use artwork with input from Engineering and Regulatory Affairs• Collaborate with QA/RA to ensure labeling meets regulatory and UDI compliance, as well as Quality Management System requirements.• Collaborate with Engineering to ensure labeling meets all dimensional, color, material and design specifications.• Initiate and manage the vendor relationship with the printer for all artwork/labeling and instructions for use.• Establish best labeling practices and standards, address text prominence, location of statements, and best fit arrangements.• Proofread text for product Instructions for Use (IFU), as well as any additional accompanying documentation.• Purchase stock images, generate final artwork copy/proof and create print-ready artwork files as needed.• Participates on project teams as needed to provide labeling updates and information.• Serve as the primary information base for all issues related to product labeling.

• Manage team with six direct reports.• Serve as an integral part of labeling project core teams.• Improve labeling processes and update DOPs (Departmental Operating Procedures) and work instructions to reflect new processes.• Run projects updating all product labels to be compliant with existing and new regulatory regulations.• Implement new labeling software and processes for better label turn times.• Serve as SME for labeling requirements with expertise in labeling standards including (but not limited to) EN 980 and ISO 15223.• Develop new labeling layouts and identify cost savings opportunities. • Perform Risk Assessment reviews of User & Functional Requirements Specification• Conduct V& V for labeling creation.• Create Engineering Change Request via Agile.• Write test scripts for manual software testing.• Organize test results and report defects found.

• Project Mangement of multiple Stay in Business projects. • Updating packaging/labeling to meet current FDA/UDI standards• Coordinate review of all division product labeling during creation or change as required.• Coordinate work assignments for temporary employees participating in labeling creation and revision activities.• Participate as lead team member on various product development projects and manage artwork for those projects.• Plan, organize, schedule, execute, track, and follow up on assigned projects to ensure projects are consistently completed on schedule. • Identify and resolve issues that impact project deliverables. • Demonstrate ownership of projects and accountability for commitments.• Communicate work progress and status of projects to Project Teams and Manufacturing personnel.• Train team members on use of graphic software and other operating procedures.• Safety Committee Procedures and Regulations committee member• Conduct quarterly mock department audits. • Use process mapping to create work instructions for department staff.• Department representative for audits.• Conduct annual review and revision if necessary for department operational procedures.• Conduct procedural gap analysis of acquired companies.

• Support product development by creating designs, illustrations, and sample layouts of product labeling based on the corporate graphic standards, packaging requirements, page layout and graphic design principles, utilize various graphic and page layout software to electronically convert concept designs and other inputs into dimensionally accurate artwork files of assembled images, text, and other elements.• Coordinate language translations activities with translation providers and facilitate the approval of multi-language labeling materials within project deadlines and in accordance with procedural and process requirements.• Prepare and finalize electronic artwork files for accurate output and convert to PDF file formats.• Troubleshoot labeling layouts where text/graphics cannot be set within current guidelines, troubleshoot with packaging department on artwork problems. • Assist and guide R&D/engineering in the preparation of product labeling, product configuration, and change control or labeling processes and systems.• Annual review of department operating procedures.• Create and release Documents via MasterControl.

Created, reviewed and revised product documentation and prepare illustrations, photographs, diagrams & charts and assist in the graphic layout of documentation.Managed the translation of manuals, labels and other technical documentation from English into other languages maintaining state, federal & international codes.

Managed an $850K+ budget to execute marketing goals.Designed marketing/public relations initiatives that included collateral creation, communications proposals, oral presentations, direct mail, and e-mail marketing.Executed project management skills for tradeshow participation and annual sales meeting.Supervised external PR and Marketing agencies for project completion.Updated internet and intranet sites using SEO positioning.

Served as lead in the creation of marketing communications projects Wrote authorization of expenditure reports to obtain financing of projects.Created promotions for industry awareness of specific products. Planned staff events including team building exercises and weekly staff meetings.

Assisted in the creation of new and existing marketing support tools. Created and maintained technical specification and installation instruction sheets for contractors and engineers. Developed scope of Video News Reels including writing scripts and photography determination.

Supported Senior Manager by collecting and evaluating pertinent market research.Collected and distributed clips from publications and clipping services. Wrote press releases. Assisted in the development of annual report and media kits. Created and edited materials for Intranet.

Edited publication for grammar, usage, style and sense. Wrote articles, headlines, captions and cut lines. Researched and compiled materials for publication.

Prepared sales proposals and manuals. Utilized desktop publishing to create forms, newsletters and press releases. Maintained employee records and other human resources duties as assigned.

Wrote press releases and biographical sketches. Revised media lists.Assisted in the development of annual report. Created program brochures, flyers and posters.

Interviewed subjects and wrote for feature stories. Edited draft of layout. Supervised staff of three writers and one photographer. Maintained operating budget.