Overview In this role you will coordinate clinical labeling implementations across Regulatory Affairs, QA Labeling, and packaging sites globally, ensuring accurate label content and mapping in Bartender. You will drive operational excellence projects and author SOPs to standardize processes. You collaborate with cross-functional teams to meet labeling goals while aligning with regulatory standards. This is a hands-on role that impacts product labeling quality and compliance at scale.
Responsibilities- Coordinate new clinical labeling implementation with Regulatory Affairs Labeling, QA Labeling, Supply Chain Labeling, BPO, PMs, and packaging sites worldwide
- Create label content and map content to Bartender fields
- Create and map Business Continuity Labels
- Review final product label content and Bartender mappings for accuracy
- Liaise with Regulatory Affairs Labeling to obtain text and timelines and ensure requirements are met
- Manage operational excellence projects without prior precedent
- Author standard operating procedures, guidelines and work instructions
- Collaborate with team members to meet departmental goals
- Complete labeling updates as assigned
Key requirements- 6+ years of relevant experience with BS/Bachelor's degree or 4+ years with MS
- Strong verbal, technical writing, and interpersonal skills
- Proficient in Microsoft Office
- Knowledge of FDA and cGMP standards and regulatory guidance documents
- Prior experience in pharmaceutical or other regulated industry
- Prior experience in clinical or commercial supply chain
- Familiarity with artwork/labeling production
- Familiarity with Bartender software (bonus)
- communication
- cross-functional collaboration
- problem solving
- attention to detail
- Bartender software
- Microsoft Office
