Job Description

Essential Job Functions:

• Execute new global content and packaging/labeling artwork in support of new product launches and base business projects in all divisions of the company.
• Accountable for ensuring that all work associated with updates or changes to global labeling standards/procedures, training plans and process improvements, routing and approval of assigned labeling deliverables through ECR and PDM processes is carried out in compliance with relevant standards and regulations.
• Evaluate the development of solutions for labeling projects, including recommending activities to resolve various business scenarios involving legacy systems, country-specific requirements, and product performance updates in conjunction with business unit labeling managers.
• Technical Editor for activities that establish labeling content and instructions for use labeling including evaluating information input into system to determine necessary content for use in labeling
• Evaluate risks and identify new alternatives to resolves critical issues
• Provide guidance to management in identifying/executing alternate solutions to accelerate timetables for critical projects.
• Develop and maintain timetables for creating new/revised content and labeling in a cost-effective manner
• Resolve non-conformance departmental/supplier issues, applying data analysis methods and specification research techniques to identify the root causes and develop corrective actions. Participate in process improvement projects and propose solutions
• Other incidental duties

Skills:

• Strong computer skills including usage of MS Office Suite; experience with MS Project preferred
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Strong leadership skills with demonstrated ability to influence change
• Proven success adhering to and leading project schedules and managing projects
• Able to read, comprehend, write, and speak English
• Substantial understanding of domestic and global development and implementation of labeling
• Substantial understanding of medical and/or pharmaceutical regulations and standards
• Substantial knowledge of medical device documentation development activities
• Knowledge of ECR, PDM, and CAPA processes
• Strong computer skills including usage of MS Office Suite
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Good project management skills
• Strong leadership skills and ability to influence change
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Work is performed independently on complex projects and/or lines of work and reviewed for accuracy and soundness

Education & Experience:

• Bachelor's Degree or equivalent preferred
• Minimum 2 years experience medical/pharmaceutical FDA regulated industry required

Company Description

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.