Description
Kelly Project Services is actively seeking a Labeling & Technical Writing Specialist for a long term engagement at one of our top clients located in Cincinnati, Ohio.
Pay rate: $40/hour + benefits
Hybrid schedule
The Labeling Technical Writing Specialist is responsible for both the technical execution and project management of package product labeling and instructions for use documents within the medical device industry. This position is responsible for supporting projects and orchestrating labeling IFU development activities that includes generating production-ready graphic artworks, completing supporting documentations, maintaining consistency of the Company s brand standards, and ensuring compliance of any graphic, labeling, and IFU content within the industry regulations, standards, and guidelines.
RESPONSIBILITIES:
- Act as the labeling representative on strategic new product development and sustaining engineering projects. Includes all labels, instructions for use, safety booklets and inserts.
- Responsible for the end-to-end development starting with gathering design requirements and specifications all the way through to the qualification and verification process.
- Provide technical writing capabilities for the content development and refinement of instructional literature including IFUs, Safety Booklets, inserts, etc.
- Review product labeling including labels, cartons, IFUs and other related materials ensuring that they meet all business, medical, legal, and regulatory requirements and standards for medical devices.
- Leads product label changes after launch based on defined needs of the business.
- Provides guidance and recommendations on labeling related processes and work instructions.
- Actively participates in process improvement activities and assessments.
- Provides guidance and recommendations for appropriate labeling materials and printing processes.
- Able to collaborate cross departmentally with product SMEs, Regulatory, Quality, Marketing, Systems and others to assess and determine label requirements and content.
- Able to support multiple projects and manage workload and task schedules appropriately.
- Ensures consistency of all graphic labeling application.
- Learns, understands and owns applicable global labeling regulations and standards.
- Will be responsible for reviewing current documentation against regulations and standards to assess gaps and needed changes.
- Equivalent of 3 5 years relevant work experience in medical industry or related field.
- Experience developing artworks, graphics and instructions for regulated industry relating packaging labels, product applied labels, reference or setup guides and product renderings or illustrations.
- Adobe Creative Suite Illustrator, Photoshop, InDesign and MS Office DESIRED
- Working knowledge of various printing processes FDA, MDR, ISO Labeling knowledge
- Project management
- Advanced proficiency with written and verbal communications
- Label creation and printing software such as Teklynx Labelview or CODESOFT a plus.
For immediate consideration, please apply online. This position is recruited for by a remote Kelly office and not your local Kelly branch.
#P1
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Apply on company website