Intern - MedTech General Labeling

This position requires working onsite in Lake Zurich, Illinois3+ days per week.

Must commit to 10 weeks of internship.

• The Labeling Intern role will support labeling related activities across the Labeling Team and across end-to-end labeling process(es) within Fresenius Kabi MedTech in accordance with global medical device regulations for medical devices, drugs, and combination products.

• The labeling Team scope includes development of strategy, creation, and management of global labeling requirements, specifications and released artwork for multiple types of manuals, instructions for use, package inserts, release notes, product & package labeling in addition to Global UDI and Global electronic instructions for use (eIFU) activities. Scope of team also includes the implementation and maintenance of labeling related platforms and tools and harmonizing legacy processes and practices across MedTech locations.

• Interns can expect to participate in global labeling requirements development, labeling & labeling component development, global UDI data / master data collection, eIFU publication, proofreading & editing of label content, localization management across product portfolio for multiple types of labeling deliverables for a variety of medical devices used in blood centers, plasma centers, and hospitals.

Specific activities / projects may include, but are not limited to:

• Support the data collection / data clean up of regulated product data for specific product codes for publication across applicable global UDI databases such as FDA GUDID, EU EUDAMED, Australia (New), Saudi Arabia, South Korea, ...

• Prepare content for new labeling system by compiling existing labeling information into templates

• With guidance, update consistent global labeling requirements (design inputs) for specific products - updating to current standards

• Support the implementation and publication of eIFU for specific product lines, including preparing legacy labeling for "electronic portability/ electronic distribution readiness"

• Support reporting and analysis of labeling related metrics related to process / tool performance and identify potential areas for ongoing improvement efforts

• Participate/view simulated procedures to improve usability of manuals for legacy devices

• Other labeling team related activities as needed

• Microsoft Office Suite including Visio and Excel. General experience with Adobe PDF reader/editing

• Attention to detail.

• Able to focus on smaller tasks to advance bigger picture goal/process. Advanced writing skills.

• Ability to distill complex process content to brief, concise, and understandable language and / or illustrations.

• Curiosity and drive to see how innovative labeling strategies and solutions can bring complex global compliance, business, technical and human factors requirements together.

• Currently enrolled as a student at an accredited college or university program; pursuing a degree related to the position

• Be classified as a minimum of a sophomore

• Must be planning to return to school at the end of his/her break

• Must commit to 10 weeks of internship

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.