Johnson & Johnson Careers

ERMC Labeling Management Associate (m/f)

Vienna, Austria
Regulatory Affairs


Job Description

Requisition ID: 1805682294W

Johnson & Johnson is the world´s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services. The values that guide our decision making are motivated by a culture of caring. Caring for the world ... one person at a time inspires and unites the people of Johnson & Johnson. The company is operating in the fields of pharmaceuticals, medical advices and consumer health care products with 117,000 employees in more than 250 companies around the world.


We are hiring a ERMC Labeling Management Associate (m/f) for our European Regulatory Management Center (ERMC). The ERMC is a regional organization to handle the majority of local company activities led by senior regional regulatory staff. It is a virtual team that handles tactical late lifecycle management processes (CMC Variations and Labeling Changes) and works in close collaboration with the respective local companies and regional and global departments.


Your responsibilities:

The overall responsibility of this Label and Translation Coordination role is maintaining perfect labels and manage Product Information translation to and from local language.

 

This includes:

 
  • Ensure the accuracy of the translated Product Information against the reference English document in compliance with EU, reference country and /or local legislations
  • Co-ordination of translation activities of English source text (eg. EU Product Information (EUPI), reference country) for the assigned cluster – in cooperation with external vendor (central or local), other Regulatory Management Center professionals, respective local companies and global departments.
  • Performing and/or co-ordination of Quality Check (QC) of local PI– in cooperation with external vendor
  • Communication with local stakeholders of the local companies during the review process

Qualifications
  • A minimum of a University degree or equivalent by experience
  • At least 2 years of regulatory experience in the local company
  • Experience of working in a virtual team and/or global organization would be an asset.
  • Previous experience in RA role as Specialist or similar role is of advantage.
  • Experience in working with limited supervision and able to make independent decisions is of advantage
  • Cultural sensitivity and ability to work and thrive in a multi-cultural environment.
  • Proactive team player, able to take charge and follow-through.
  • Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
  

The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.

 

We offer excellent conditions of employment and possibilities for further career growth within our company. For this position we are offering an annual gross salary starting at 45.100 EUR (excl. variable component). Depending on your skills, qualifications and experience this can be negotiated.



Primary Location
Austria-Vienna-
Organization
Janssen Cilag Pharma GmbH (8558)
Job Function
Regulatory Affairs
Requisition ID
1805682294W