Kelly Services Graphics Specialist in Rochester, New York
1+ year contract
Labeling supports Pharma and Medical Device Regulatory Labeling team with creation of strategy and managing milestones and timelines.
Collaborates with Regional labeling teams to coordinate and perform assessment to determine scope of work and impact related to identified changes in scope of projects.
Prepares global strategy for project based on completed assessment.
Develop and manage project objectives, establish labeling lead times and detailed schedules in connection with Medical Device and Pharma Project Labeling.
Maintains project schedule by monitoring project progress, coordinating labeling impact activities, resolving issues, tracking dependencies, and proactively managing risks to ensure projects meet targeted artwork release dates.
Manages milestone activities Label Assessment, Redlines, meetings, SPL due dates for Regulatory Labeling Leads to support project timelines across global labeling process.
Develop and maintain effective cross-functional partnerships and network within RA and key stakeholders including QA, Supply Chain to prioritize and drive key project labeling strategies, prioritization of labeling changes, project goals, and timelines.
Create tracking tools and dashboards to monitor all labeling change deliverables across multiple manufacturing facilities, regions, and projects.
Support team with other labeling activities as needed Medical Device, Pharmaceutical and Consumer Labeling Internal business functions and external partners related to the development, execution, and implementation of regulated labeling.
Strong technology skills and abilities, especially with Microsoft Office programs, and web-based programs.
Ability to critically and efficiently review detailed information to support a labeling revision.
Demonstrated ability in analytical reasoning and critical thinking skills.
Strong communication skills; both oral and written.
Strong interpersonal skills with the ability to influence others in a positive and effective manner.
Ability to identify and communicate potential issues and escalate as necessary.
Strong project management and organizational skills.
Proven track record on delivering large scale projects.
Ability to manage complex projects and timelines.
4+ years relevant medical device / pharmaceutical industry and regulatory experience, Bachelor s degree preferred, applied knowledge of global labeling requirements.
Why Kelly ® ?
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we’re here every step of the way to find your dream engineering job.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
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