Proofing and Repack Relabel Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Project/Program Management Group Job Sub Function: Project/Program Management Job Category: Professional All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ DUTIES & RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position is responsible for: Quality control points within the label design and development process to ensure labeling meets design requirements.

Verification of labeling for New Product Development (NPD), Lifecycle Management (LM) and Process improvement projects for the Labeling. Responsible for communicating business related issues or opportunities to next management level.

For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Performs other duties assigned as needed. Compare artwork against source documentation and/or previous artwork versions by utilizing proofing requirements to identify discrepancies in content, format, grammar, punctuation, electronic navigation (hyperlinking), spelling, symbology, etc.

Follow established procedures to verify/proof and edit product labeling and packaging graphics. Document results of verification as per Good Documentation Practices and provide as feedback for iterative design work by graphic designer.

As necessary, approves proofs, blue-lines, or color chromes supplied by vendors. As necessary, verify design templates required to complete standardized label/IFU work.

Regularly update stakeholders on proofing status. Use company-specific documentation systems to manage the storage and release of documents.

Provide writing, proofreading, and project management skills to ensure labeling and IFU projects are executed with accuracy. Works within the context of standard editing procedures.

Support special projects as required. Assign resources to coordinate activities for proofreading .

Proofreads assigned projects in production to ensure they meet established company and professional standards, contain correct information, and conform to project parameters. Checks and edits work of less experienced proofers.

Lead proofing related process improvements. Develop/maintain proofing guidelines, including improving/standardization of proofing practices.

Participates in or leads technology evaluation and process improvements to improve proofing capability. Supports process/repack & relabel improvement initiatives within the department and company.

Maintaining repack & relabel records of intake, in process, and dispositioned requests. Coordination of communication with repack & relabel council members, requestors, and ad hoc reviewers, including meeting schedules, status, pre-work, agendas, and minutes.

Develop and maintain analytics and metrics of the Council effort. Provide input to, initiate, and/or leading improvements to the process.

Maintain and find opportunities to improve or enhance local repack & relabel procedures. Providing training and audit and escalation support for the process.

Provide leadership and collaborate with stakeholders to plan approaches for compliance, review, and disposition of both legacy and new processes. Support quality escalations and CAPAs as appropriate.

Qualifications: Education: Minimum of a Bachelor’s or equivalent University Degree required Experience: Minimum 2 years of relevant work experience Strong correspondence and documentation composing skills Project management skills, preferred Strong written and oral communication skills Interdependent partnering Mastering complexity Ability to manage multiple projects competing for resources Analytic problem solving Technical writing, editing and proofing Domestic and international regulatory and legal regulations Change Management concepts and methods Basic proofreading skills and knowledge Ability to work with a high degree of concentration for several hours at a time Fundamental knowledge of the English language; grammar and spelling Organized and detail oriented Influence and conflict resolution Other: May require up to 10% domestic and/or international travel to other locations and sites Johnson & Johnson