Clinical Affairs Manager (f/m/d)
GEROT LANNACH is a private-owned Austrian company developing, producing and allocating unique brand-name products as well as generics for the well-being of people in Austria and abroad. As an international player, we market our products through our licensees and branch offices to more than 50 countries.
For our Medical and Regulatory Affairs Department, we are hiring a
CLINICAL AFFAIRS MANAGER (f/m/d)
at our Head Office based in Lannach, Styria.
- Implementation and oversight of clinical studies in direct responsibilities
- Preparation, planning and coordination of clinical studies
- Organization and management of study relevant documents
- Collaborating with and managing external partners (vendors, contract research organizations)
- Supporting regulatory interactions addressing clinical questions and responses
- Writing and preparation of all clinical documents for submission to regulatory authorities
- Writing and preparation of scientific advice documents
- Communication with regulatory authorities
- Clinical support of colleagues within the department and throughout the company
- Communication of information relevant for the colleagues within the department and throughout the company
- Natural science/scientific background (FH, university)
- At least 3 years experience in pharmaceutical industry
- Experienced in medical writing of clinical and regulatory documents
- Experienced in clinical trial development
- Good knowledge of international and national/regional guidelines and regulatory topics
- Being able to work independently, manage multiple projects
- Fluency in English and German (written and spoken)
What we offer:
- Attractive working environment in a medium-sized modern company with good transport links
- Excellent possibilities to gather experience in a multi-professional team
- Attractive social benefits
- Wages in accordance with the current Austrian Collective Agreement (Pre-Tax Year’s Salary EUR 47.445,52 for a 38 working hours in a week) we are willing to overpay according to your qualification and experience.
We are looking for ambitious, highly qualified and motivated employees, who are team-oriented and willing to show self-initiative. We recruit employees who share GEROT LANNACH’s philosophy of innovation and growth and are willing to develop on both a personal and an educational level.
If you can identify yourself with our vision, we are happy to receive your application.