ALSINOVA is hiring a Clinical Trial Labeling Specialist on hybrid model (remote + on-site)
Sites : Raleigh, NC or Greater Philadelphia, PA
Job Responsibilities
- Work within a global team. Create master label content according to existing processes and procedures, designing Clinical Trial labels.
- Perform quality critical checks of label content produced in various languages to required timelines.
- Perform quality critical checks of externally produced vendor label proofs prior to receipt.
- Creation of label documentation, required for in-country regulatory submissions, in a timely manner.
- Highlight label quality issues.
- Work with external vendors (translation service provider, component suppliers etc).
- Participate in GPM team meetings. [GPM stands for Global Pack Management]
- Liaise with other groups within Clinical Manufacturing & Supply Chain.
- Work in key IT systems – SMARTLS Compliance Author, Adobe InDesign, Prisym 360.
Experience Required
- Able to follow written instructions, shows a good degree of accuracy and attention to detail.
- Good knowledge of Clinical Supply requirements, standards and GMP regulations.
- Good understanding of Clinical Supplies packaging, labeling and distribution plus related paperwork.
- Self-assign core tasks, prioritizing and completing as part of a wider team with minimal supervision/input.
- Bachelor degree
- 2 years of pharmaceutical experience including cGMP environment or compliance role or auditing role.
- Experience with clinical trials is preferred.