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Clinical Labeling Operations Specialist
DAWAR CONSULTING INCClinical Labeling Operations Specialist managing labeling updates across regulatory teams for a biotech leader. Overseeing compliance with FDA regulations and enhancing operational excellence.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in coordinating global clinical labeling implementation, ensuring compliance with FDA regulations and cGMP standards, while effectively managing project timelines and cross-functional collaboration. Proficient in technical writing and authoring SOPs to support operational excellence in the pharmaceutical industry.
Highest-signal resume keywords
Clinical Labeling ImplementationFDA RegulationsCGMP StandardsProject CoordinationBartender Software
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Label Content MappingTechnical WritingSOP AuthoringProcess ImprovementRegulatory Guidance
Soft Skills
CommunicationInterpersonal Skills
Tools & Technologies
Microsoft OfficeBartender Software
Industry Keywords
Pharmaceutical IndustryRegulated IndustryClinical Supply Chain OperationsArtwork Production
About the role
Key responsibilities & impact- Coordinate global clinical labeling implementation with Regulatory Affairs, Quality, Supply Chain, PMs, and packaging sites.
- Create and map label content within Bartender and develop Business Continuity Labels.
- Review final product label content and mapping for accuracy and alignment with source documents.
- Partner with Regulatory Affairs to obtain approved text, manage timelines, and ensure requirements are met.
- Lead operational excellence and process improvement projects.
- Author and update SOPs, guidelines, and work instructions.
- Support labeling updates and collaborate cross-functionally to meet departmental objectives.
Requirements
What you’ll need- Bachelor’s degree with 6+ years of relevant experience, or Master’s degree with 4+ years of relevant experience
- Experience in the pharmaceutical or other regulated industry
- Experience with clinical or commercial supply chain operations
- Familiarity with pharmaceutical artwork and labeling production
- Knowledge of FDA regulations, cGMP standards, and regulatory guidance
- Strong project coordination, communication, technical writing, and interpersonal skills
- Proficiency with Microsoft Office
- Preferred: Experience with Bartender software and label content mapping
Benefits
Comp & perks- Medical
- Paid Sick leave
- 401K