Intern - Labeling

Fresenius Kabi

Feb 4

Applications are closed

Internship
Full-time
Summer Internship
Science
Chicago

Requirements

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.
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.

Responsibilities

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.
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

Fresenius Kabi

Manufacturing & Electronics

Industry

10,001+

Employees

1912

Founded Year

Mission & Purpose

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its “Vision 2026”, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.