Labeling Operations Manager, Associate Consultant
Core
Provide operational support for the creation and updates of regulatory labeling documents (CDS, USPI, SPC) and patient labeling for pharmaceutical products.
Role type
Associate Labeling Operations Manager (Project Management & Document Operations)
Builds
Regulatory labeling documents and patient labeling materials for pharmaceutical products
Domain
Life Sciences / Regulatory Affairs
Required skills
Project management, document management workflows, regulatory compliance (QRD/PLR), Microsoft Word, stakeholder communication, deadline tracking
Preferred skills
Science or life sciences background, problem identification and resolution, shadowing training
Technologies
Microsoft Word, Document Management Systems
Responsibilities
Prepare comparison tables for labeling discussions, generate clean and marked PDF/Word renditions, finalize documents after QC, consolidate comments from reviewers and authorities, update CDS logs, set and track project timelines, provide shadowing to trainees
Seniority
Junior, hands-on IC
