Fresenius Kabi - Regulatory Writer (m/f) - Germany


Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients.

Regulatory Writer (m/f)

For writing regulatory documents of parenteral nutrition products, the Regulatory Writing Department at Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany, is looking for a writer (f/m), employed or contracted, starting from 01. April 2018.
Depending on qualification, deliverables include clinical parts of CTDs, clinical responses in reply to questions from authorities, and other regulatory documents such as briefing packages for scientific meetings and paediatric plans. Literature searches and handling the output is required as well as contribution to Project Teams.

We are looking for an independent, reliable, detail-oriented team player with analytical thinking, high cooperation level, and good communication skills. Education is expected in a relevant subject such as natural sciences or linguistics, preferably with university degree. Minimum of 3 years working experience in medical/scientific field, clinical research, or regulatory affairs; experience in writing CTDs is an advantage.

Please send your application to Dr. med. Petra Minnasch, Director Regulatory Writing Parenteral Nutrition
Fresenius Kabi Deutschland GmbH
Else-Kröner-Str. 1
D-61352 Bad Homburg