Labeling Manager (m/w/d)

 Qualifications:

The ideal candidate has minimum a bachelor’s degree and/or at least 2 years’ experience in the clinical supplies space (packaging/ labelling operations).

• The individual must possess excellent communication skills

• Excellent organizational skills, time management skills

• Very good German and English skills

• Able to work independently

• Analytical thinking

• Eye for detail

• Able to work in the GMP environment

• Team player

Responsibilities:

The primary activities include but are not limited to:

• Creation and approval of label text translations with the aid of systems (Clinical Label Proof Generator and the electronic document database).

• Creation and approval of the translations and corresponding documents with regards to the study-specific, company-internal and country-specific regulatory requirements.

• Creation and monitoring of the project schedule and coordination of projects from the label translation to the delivery of the labels to the packaging department.

• Ensures through effective project management that the communication to the relevant locations is guaranteed at all times and the project requirements can be met.

• Consultation of the responsible project manager with regards to the determination of the label text in compliance with international regulatory requirements and internal company standards.

• Provides input and partners with other work centers to develop the packaging/labelling strategy for the individual clinical products in regards of label text.

• Participates regularly in internal and global coordination meetings

• Maintenance of the label generation documentation according to GMP Standards.

• Review of label generation documents according to study specific and regulatory requirements.

Good Manufacturing Practices and Compliance in general: Follows workflows and procedures according to current SOPs

Working time: Working time starts between 8-9h. There are some regular meetings with counterparts in US in the afternoon (estimated to be approx. 3-5h./week).

Commuting: The candidate is expected to work 2-3 days/week on-site.