DRA Assistant (m/f) RCV Animal Health - Part-time (19 Hours/Week)
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
DRA Assistant (m/f) RCV Animal Health
Part-time (19 Hours/Week)
Duties & Responsibilities
- Translation, preparation or review of SPC/labelling/leaflet texts from Company`s respective new and in-line products registered in the countries, or coordination of these activities - under supervision. Artwork revision for AT and coordination within sub-region
- Support in preparing Application Forms and other local documentation including payment of registration fees under supervision of DRA Manager
- Tracking the product status and product maintenance in appropriate database for defined region
- Cultivating best possible relations with local regulatory bodies
- Under supervision of DRA Manager handling all issues related to changes in the Company's products status in line with regional strategy and performing regulatory related surveys in the region
- Dealing with pharmacovigilance related issues within the appropriate region (reporting of PV cases, databases update, training of the colleagues, keeping the pharmacovigilance archive, PSUR submission)
- Support of AH DRA RCV team in administrative tasks
- Support DRA Manager in marketing material revisions
- Establishing and maintaining support and good contacts within corporate, regional and local regulatory teams, business, marketing and logistic functions, taking into consideration Company's interests and normative requirements
- Effectively communicate with regulatory authorities
Please note that this employment will be organized through an external service provider. The Employment takes place exclusively in Vienna at Boehringer Ingelheim RCV GmbH & Co KG.
For this position we offer an interesting salary considering your expertise and personal competencies as well as your professional experience. We are obliged by law to state the minimum salary according to the collective agreement, which amounts to € 34,142.50 gross per year (full-time) for this position. An overpayment is possible. Moreover, we offer our employees a variety of attractive social benefits which will be introduced in the personal interview.
- Scientific background (ideally Veterinary Medicine)
- German, English (fluent in writing and verbal)
- Computer literacy (MS Office)
- Past experience in Regulatory Affairs (not necessary but welcome)
- Willing to learn new things, implementation of legal conditions into in-house procedures
- Ability to work remotely with the team in RCV/CEE countries and thus cultivating the relationship and team spirit within multi-cultural environment
- Motivation in details and analyses of scientific/regulatory texts
- Being able to work towards priorities and under time-pressure
- Ability to read drug law legislation and authority requirements
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.
Your application will be reviewed by our recruiting team as well as the respective department. Therefore, we do not state a specific contact person and kindly ask you to use a general salutation in your application.
Job: Administrative and Secretarial Support
Primary Location: Europe-Austria-Vienna-Vienna
Organization: AT-Boehringer Ingelheim Regional Center Vienna GmbH & Co KG (Austria)