Funktionsziele:
Erstellung von toxikologischen Statements und Bewertungen.
Berechnung von regulatorisch relevanten Grenzwerten für Substanzen und Produkte einschließlich deren toxikologischen Bewertung
Mitarbeit an den pharmakologisch-toxikologischen Zulassungsdokumenten gemäß CTD.
Ihre Aufgaben
- Sie sind verantwortlich für die Berechnung von regulatorisch relevanten Grenzwerten (z. B. PDE, OEL) für Substanzen und Produkten sowie deren toxikologischer Bewertung.
- Sie führen selbständig Reviews der toxikologischen Assessments von Junior Toxicologists, Toxicologists und Senior Toxicologists durch
- Sie sind für die Sicherung und Weiterentwicklung der Qualitätsstandards im Bereich Toxikologie verantwortlich.
- Mitarbeit am pharmakologisch-toxikologischen Teil der Prüfarztinformation, bei Anträgen zur Genehmigung klinischer Studien sowie Dokumentationen für Behörden
- Unterstützung des internen Extractable & Leachable Forums
- Sie sind ebenfalls bei der Erstellung von Präsentationsunterlagen und Teilnahme an Meetings mit internationalen Zulassungsbehörden eingebunden.
- Review der präklinischen Protokolle und Abschlussberichte
Ihr Profil
- Sie haben ein erfolgreich abgeschlossenes Studium der Tiermedizin, Biologie oder Chemie/Biochemie
- Sie haben eine Promotion abgeschlossen
- Sie haben eine zusätzliche abgeschlossene Qualifikation als "Diplomate of the American Board of Toxicologists (DABT)" oder sind "European Registered Toxicologist (ERT)"
- Sie haben bereits mehrere Jahre Berufserfahrung innerhalb eines internationalen Unternehmen mit Matrix Struktur sammeln können
- Sie erarbeiten sich selbständig neue Themengebiete und betreuen eigenverantwortlich verschiedene Fachgebiete und Aufgabenbereiche
- Sie besitzen fließende Deutsch und Englischkenntnisse (in Wort & Schrift)
- Sie bringen ausgeprägte IT Kenntnisse mit
Your benefits
FlexBenefits
Deutschlandticket, job bike or would you prefer an increase in the childcare allowance? With the Fresenius FlexBenefits program, you can choose the benefit that suits your needs and your current life.
Career with a Purpose
With your job, you make a valuable contribution to improving patients' quality of life around the world.
Long-term Account
Whether it's training, caring for family members, early retirement or a period of absence - the long-term account offers various time-off options.
Pension Plan
At Fresenius, you receive an employer-funded company pension plan in addition to your salary.
Childcare Allowance
If you have children, you can apply for a financial allowance which is transferred monthly in addition to your salary.
Health at Work
We offer you a wide range of sports, nutrition trainings and preventative services.
Direct Insurance
Fresenius supports you in setting up your direct insurance – so you can benefit from the attractive conditions of our Group agreement.
Accident Insurance
At Fresenius, you are covered for accidents every day of the year, anywhere in the world. In addition, you can also insure your family.
Individual Professional Development
We promote you with professional development programs and support lifelong learning throughout your career.
Employee Discounts
We offer you to benefit from a program with attractive discounts on products and services from well-known retailers.
Corporate Catering
Our company restaurants provide you with freshly prepared meals every day.
Food Allowance
You can purchase food and drinks at a discounted price in our company restaurants.
Company Medical Service
The company medical service is available for consultation, first aid in the event of occupational accidents or reintegration.
Transport Connection
Most of our locations are very well connected to highways, bus stops or train stations.
Parking Lots
Free parking lots are available at many of our locations.
Sports Activities
Depending on the location, we offer a wide range of sports activities - from company runs and sports badges to tournaments and competitions.
Hybrid Working
Working from home or in the office or both? There are various offers for hybrid working that give you a lot of flexibility.
Employee Participation Program
With Fresenius SHARE, we let our employees participate in the company's performance through a share program; in addition, we enable them to buy shares at very favorable conditions.
Tariff-based supplementary long-term care insurance scheme
Employees covered by the collective bargaining agreement will be collectively insured by the employer against the risk of long-term care - without a health check.
Show all 19 services
At a glance
Location:
HessenOberursel
Career level:
Professional Experienced
Job Function:
Regulatory Affairs / SafetyResearch & Development
Employment relationship:
PermanentFull-time
Division:
Fresenius Kabi
Reference number:
62102
Publishing date:
06/25/2024
As long as the job ad is online, you can apply quickly and easily.
Add job to watchlist
Your contact
Swantje Kohl
Fresenius Kabi Deutschland GmbH
Bad Homburg
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We welcome diversity
At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.
All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).
Careers with a purpose
When it’s not just a job, but your calling. When you have an impact on people’s lives every day. When you can’t imagine doing something else. Then you know it’s Fresenius.