Description
A pharmaceutical company in South San Francisco is looking for a Manager, Labeling to join their team. This is an excellent opportunity to join a growing organization with an exciting pipeline. The Manager, Labeling will manage the preparation, review and approval of artwork for printed components used to package commercial drug product. Responsible for timely approval of artwork to be used for printed components. Generates change controls and coordinates approvals of artwork. Make improvements to streamline artwork approval operations. Assist in implementation of proof-reading software.- Coordinate the preparation of label copies and proofs for labels, cartons and package inserts.
- Review artwork against labeling submitted in regulatory filings and regional requirements.
- Coordinate the timely review and approval of label copies and proofs with Manufacturing, QA, Regulatory, Marketing, Legal and other cross functional groups.
- Coordinate artwork approval timelines with Supply Chain and packaging vendors and ensure that production timelines are met.
- Recommend improvements and develop processes/SOPs to enhance efficiencies that are in compliance with GMPs
- Assist in validation and implementation of new proof-reading software
- B.S. in a Life Science or related technical discipline.
- Extensive experience in pharmaceutical industry with strong hands-on knowledge of artwork approval process and GMPs.
- Must be familiar with software and/or terminology used in the printing industry.
- Experience with managing artwork for global commercial drug product is a plus.
- Ability to work both independently and in a team environment with a proven ability to manage multiple priorities under tight timelines.
- Must be flexible and able to respond to changing priorities in a fast paced environment.
- Excellent interpersonal, organizational, and communication skills are required
To find out more about Real please visit www.realstaffing.com