Pfizer
Pharmaceuticals
HubLabeling&ArtworkSeniorAssociate/CoordenadordeDocumentaçãodeRotulaçãoeArte
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“Hub Labeling & Artwork Senior Associate / Coordenador de Documentação de Rotulação e Arte at Pfizer. Skills: Labeling content management, Regulatory compliance, Documentation submission. Execute content management of LPDs. Execute content management of LLDs”
What You'll Achieve.
Meet productivity targets; Meet quality targets; Meet compliance targets
Industry & Context.
Problem-solving skills
On-site 2-3x/week
What They're Looking For.
Must Have
Demonstration of attention to detail, Problem-solving skills, Proven technical aptitude, Ability to learn new software, Ability to learn regulations, Registration experience, Ability to assess regulatory implications, Knowledge of global/regional guidelines
Nice to Have
Develop positive working relationships, Interpret and apply regulatory guidance, Project management skills, Country office experience, Regional Regulatory Strategy experience, Core Data Sheet implications knowledge
What You'll Do.
Execute content management of LPDs
Execute content management of LLDs
Execute content management of PLDs
Provide labeling support
Maintain system management for labeling
Maintain workflow management tools
Provide ad hoc support
Perform QC of labeling text
Monitor system data integrity
Perform quality checks
Contribute to moderately complex projects
Produce non-complex LPDs
Produce non-complex LLDs
Produce non-complex PLDs
Produce labeling-related documentation
Perform QC check of colleagues' work
Identify process improvements
Identify system improvements
How You'll Work.
Team & Collaboration
Work with Hub Labeling Managers; Collaborate with other functions; Work with Pfizer PCOs; Work with GRS groups; Work with GRO groups
Communication Scope
Written communications; Verbal communications
Process & Methodology
Project management
Full Job Description
## **Hub Labeling & Artwork Senior Associate** Is responsible for executing the content management of non-complex Local Product Documents (LPDs), Local Label Documents (LLDs) and Patient Leaflets (PLDs) for nationally registered products for their assigned products across multiple countries/regions. Provides associated labeling support to the rest of the ILG organisation, working in collaboration with Hub Labeling Managers. **JOB RESPONSIBILITIES** · Supports Hub Labeling Manager (Manager) by maintaining system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system. Maintenance of workflow management tools and mailboxes. · Provides ad hoc support for labeling deliverables. · Performs QC of labeling text. · Monitors system data integrity and quality checks. · To maintain system management for labeling activities including GDMS and Pfizer approved labeling tracking system. · Contributes to the completion of moderately complex projects under the direction of more senior labeling managers. · Utilizes regulatory knowledge to produce non-complex LPDs, LLDs and PLDs where there are unambiguous relationships to source documents and clear local regulatory principles to follow, requesting advice or input from other functions when appropriate. · Produces other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supporting documentation. · Performs QC check of other colleagues’ work. · Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers. · Meets defined targets on productivity, quality and compliance, as set by and overseen by management. **SKILLS** · Basic knowledge/understanding of the principles and concepts of labeling. · Basic knowledge of key regulatory and labeling principles and local regulations. · Proficient in use of systems consistent wi
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