INTERN-MEDICAL DEVICE LABELING

• The Labeling Intern role will support labeling related activities across the Labeling Team and across end-to-end labeling process(es) within the Fresenius- Kabi MedTech Transfusion and Cell Technologies (TCT) Division in accordance with global medical device regulations for medical devices, drugs, and combination products.
• 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 serts, 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 TCT and MedTech locations.
• Interns can expect to participate in global labeling requirements development, labeling & labeling component design (e.g. desktop publishing, technical illustrations), technical writing, global UDI data / master data collection, eIFU publication, proofreading & editing of label content, translation / 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:

• Review / Revise / Create drawings, specifications, labels, and instructions for use
• Create Charts, Graphs, flow charts, spreadsheets, and / or forms for illustrative contents
• With guidance, run simulated procedures to improve usability of manuals for legacy devices
• With guidance, create / update consistent global labeling requirements (design inputs) for specific products - updating to current standards
• 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,
• Support the implementation and publication of eIFU for specific product lines, including preparing legacy labeling for "electronic portability/ electronic distribution readiness"
• Preparing reports, analytics, and analysis of labeling related metrics related to process / tool performance and identify potential areas for ongoing improvement efforts
• Other labeling team related activities as needed

Requirements

• Currently enrolled as a student at an accredited college, university PharmD program.
• Be classified as a minimum of a sophomore.
• Must be planning to return to school at the end of their break
• Design, Graphic Arts, and / or instructional design focus preferred.
• Technical Writing / Professional writing skills.
• Microsoft Office Suite, MS Illustrator, Visio, Adobe.
• 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.
• Intern candidates must be permanently authorized to work in the U.S.
• Our internships are unable to accommodate OPT.
• Interns are responsible for their own housing.

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