Job Title:
Clinical Label Manager
----------------------------------- About the Role:
The Clinical Label Manager is responsible for proposing label sizes and study designs based on country-specific label text, serving as a subject matter expert for various questions on clinical labels from other teams, coordinating/advising Operations Planner on label strategy for a clinical packaging job, reviewing country-specific label text on accuracy and regulatory requirements, handling randomization schedules for clinical studies, reviewing and releasing label batch record documents, ensuring activities are completed within given timelines and timely escalation when issues arise, designing Clinical Labels for primary and secondary packaging jobs, and working according to GMP standards and internal guidelines.
----------------------------------- Responsibilities:
- Propose label sizes and study designs based on country-specific label text.
- Serve as SME for various questions on clinical labels from other teams.
- Coordinate/advise Operations Planner on label strategy for a clinical packaging job.
- Review country-specific label text on accuracy and regulatory requirements.
- Handle randomization schedules for clinical studies.
- Review and release label batch record documents.
- Ensure activities are completed within given timelines and timely escalate when issues arise.
- Design Clinical Labels for primary and secondary packaging jobs.
- Work according to GMP standards and internal guidelines.
----------------------------------- Requirements:
- Minimum an Apprenticeship (Laboratory, Pharmacy, Business administration etc.) and at least 2 years experience in clinical supplies packaging/labeling operations.
- Familiarity with GMP requirements, quality procedures, and SOP execution.
- Flexible and team-oriented.
- Proven ability to organize and manage multiple tasks at one time and meet deadlines.
- German and English (verbal and written) at B2 working level required.
----------------------------------- Employment Details:
- Start: Immediate start possible.
- Duration: 12 months.
----------------------------------- Seniority Level:
Associate.
----------------------------------- Job Function:
Supply Chain.
----------------------------------- Industries:
Pharmaceutical Manufacturing.