/ CAREER WITH A PURPOSE /

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.

Medical Information Manager (m/f/d)

Contribution to regulatory registration procedures comprising clinical documentation e.g. new drug applications, variation procedures, deficiency reports and renewals sounds appealing to you? Then join our team in Oberursel (near Frankfurt/Main) and support Fresenius Kabi observing the highest level of operating procedures!

More

Contribution to regulatory registration procedures comprising clinical documentation e.g. new drug applications, variation procedures, deficiency reports and renewals sounds appealing to you? Then join our team in Oberursel (near Frankfurt/Main) and support Fresenius Kabi observing the highest level of operating procedures!

Your assignments

  • Contribution to regulatory registration procedures comprising clinical documentation e.g. new drug applications, variation procedures, deficiency reports, renewals etc.
  • eCTD-compliant preparation and quality control of documents in the electronic document management system
  • Contribution regarding competent authority communication, e.g. scientific advice meetings and response documents
  • Contribution to project planning, organization, implementation, monitoring and evaluation of non-interventional studies as well as phase I - IV clinical studies according to ICH-GCP or other applicable regulations and SOPs.
    This includes following activities:
    • Cooperation regarding the coordination of the preparation of the clinical study protocol, the case report forms (CRFs) and the clinical study report
    • Sponsor "Oversight" at the study center and the CRO as well as Co-Monitoring activities
    • Collaboration in the organization and in the conduct of investigator meetings and DSMB meetings
    • Organization and preparation of study documentation (e.g. Trial Master File) and corresponding archiving
    • Quality assurance activities
    • Preparation and attendance of audits and inspections
    • Ensuring the necessary entries in study and innovation databases

Your profile

  • Natural scientific, pharmaceutical or comparable academic study
  • In the last 3 years being active in the field of medical documentation, clinical research incl. monitoring and participation in investigator meetings
  • Long-standing involvement in planning, organization, supervision, execution and evaluation of clinical trials according to ICH-GCP
  • Experience in planning/organization of audits and inspections
  • Current professional experience in dossier creation, dossier standards and regulatory registration processes
  • Interest in innovation
  • Fluent in spoken and written English
  • Confident handling of MS Office and other IT tools such as databases
  • Flexibility, initiative and teamwork

At a glance

Career level:

Professional Experienced

Job category:

Clinical Trial / Statistics

Working condition:

Permanent contract / Full-time

Business segment:

Fresenius Kabi

Location:

Oberursel / Hessen

Closing date for applications:

none - we look forward to your application

Your contact

  • Verena Rudolph
  • Fresenius Kabi Deutschland GmbH
  • Bad Homburg
  • Ref. number: 30528
  • 06172 686-7198

About Fresenius

Career with a purpose:

Over 270,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.

career.fresenius.com
fresenius.com

 

One of Fresenius' strengths:

our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility.

More reasons

 

The benefits we offer:

Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.

More benefits

Your contact

  • Verena Rudolph
  • Fresenius Kabi Deutschland GmbH
  • Bad Homburg
  • Ref. number: 30528
  • 06172 686-7198
Career level:

Professional Experienced

Job category:

Clinical Trial / Statistics

Working condition:

Permanent contract / Full-time

Business segment:

Fresenius Kabi

Location:

Oberursel / Hessen

Closing date for applications:

none - we look forward to your application

About Fresenius

Over 270,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
career.fresenius.com
fresenius.com

One of Fresenius' strengths:

our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility.

More reasons
The benefits we offer:

Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.

More benefits