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Pharmaceutical Label Specialist
Ref No.: 19-00181
Location: Ridgefield, Connecticut
Responsible for managing and performing tasks along the Clinical Trial Supply Chain, especially related to the generation of labels, which includes vendor management tasks.
Responsible to perform and document tasks in compliance with regulations, policies and industrial need.
Information provision and ordering: Review, check and approval of English Master Label Text (EMLT); Pre-translation and routing of EMLT, receipt of translations, follow up of translations, generation of Approval Form, specify design of labels, recieve print proofs, route printproofs for approval, order booklets from vendor, filling of related GMP documents ]
Responsible to ensure and support timeline and quality of clinical supplies, as well as cost efficiency, safety culture and lean business
Continuous improvement/innovations: Management of label team tasks for internal and external packaging and labeling of IMPs for assigned projects and clinical trials.
Create and optimize workflows and processes with label vendors, label approval vendors and partners as well as packaging & labelling group.

Background in Clinical Trials (Supply Chain, Clinical Trial Regulations, Packaging and Labeling area, medical documentation)
Experience with labeling needs & processes i.e. Food industry

Demonstrates knowledge of all areas of clinical supply chain activities and a thorough knowledge and understanding of applicable US and EU regulations
Solid project management skills
Ability to interpret standard and complex project requirements
Strong problem solving, risk assessment and troubleshooting skills
Good knowledge and understanding of applicable regulations
Work independently and in a team environment.
Candidates qualified for the assignment may have had positions as a Supply Chain Project Coordinator
Vendors the Specialist will be working with ...
- Label manufacturers
- Packaging and Labeling vendors for Clinical Trials
Other team members will be ...
- Head PLC Labeling located in Biberach
- PLC Label Specialists located in Biberach
- PLC Label Experts located in RDG and Biberach
- total 5 people