Job Summary
The Labeling Operations Manager (LOM), Associate provides operational support for the initial creation and relevant updates to labeling documents, including Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents.
The LOM, Associate will be knowledgeable of labeling guidance and policies related to technical and formatting requirements, such as the QRD template and PLR format, and will raise awareness of important factors to consider when revising the label.
The LOM, Associate provides project management to the Labeling Team throughout the labeling review and approval process through notification to stakeholders, ensuring that documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets, ensuring Labeling Teams are aware of review and approval timelines, and following up with team members so deliverables remain on target for internal and external deadlines.
Job Responsibilities
Support the review and delivery of labeling documents and their associated Patient Labeling Documents. The LOM, Associate supports non-complex products and projects.
Labeling Operations Manager - Associate 1
Provides operational support for project tasks, including:
- Prepare comparison tables for labeling team discussions.
- Generate necessary renditions, such as clean and marked PDF and clean and marked Microsoft Word, and bookmark renditions as appropriate.
- Facilitate document management workflows through the appropriate document management system.
- Finalize documents after QC.
- Notify internal stakeholders of the availability of labeling documents.
- Ensure compliance with Company submission standards, policies and procedures. Ensure all actions follow applicable SOPs and associated documents so that high-quality delivery and compliance are maintained.
Labeling Operations Manager - Associate 2 (in addition to Associate 1)
Provides operational support for simple projects, including:
- Consolidate comments from Labeling reviewers and Regulatory Authorities.
- Edit and format labeling documents and ensure compliance with the appropriate template, such as QRD or PLR.
- Update and maintain the CDS log.
- Set clear targets for review and approval timelines using effective project management. Follow up with Labeling Team members to ensure deadlines are met.
- Ensure appropriate tracking of labeling projects through defined procedures and optimal use of systems.
- Provide shadowing opportunities to Trainee LOMs.
Qualifications / Skills
Qualifications and skills necessary for performance of responsibilities, including education, relevant experience, licenses, certifications, and technical and managerial skills.
Qualifications
Education
- Bachelor's degree required, preferably in a science or life sciences-related field.
- 0-2 years of practical experience.
Labeling Operations Manager - Associate 1
Experience and Attributes
- Excellent written and verbal communication skills.
- Complete fluency in English.
- Proven strength in logical, analytical and writing ability.
Interpersonal and Communication Skills
- Clear and effective written and verbal communication skills.
Technical Skills
- High attention to detail.
Systems and Document Compilation Skills
- Excellent computer skills and proficiency with Microsoft Word and similar applications.
Labeling Operations Manager - Associate 2 (in addition to Associate 1)
Experience and Attributes
- Identifies and resolves problems proactively.
Project Management Capability and Organizational Skills
- Demonstrated project management skills and attention to detail.
- Ability to assess and manage project timelines.
- Ability to multitask, prioritize and manage multiple projects.
- Ability to identify and resolve problems proactively.
- Appropriate decision-making, including issue escalation to the Global Labeling Lead (GLL) and other appropriate stakeholders.
Interpersonal and Communication Skills
- Ability to liaise with stakeholders using effective means of communication.
Technical Skills
- Ability to apply labeling regulatory guidance on formatting requirements.
- Ability to consolidate comments from multiple sources, such as emails and meeting minutes.
- Knowledge of labeling guidance and policies related to technical and formatting requirements, such as the QRD template and PLR format.
Systems and Document Compilation Skills
- Excellent computer skills and proficiency with Microsoft Word and similar applications.
- Ability to prepare submission-ready documents.
Organizational Relationships
Provide the primary groups or key roles with which this role interacts regularly, including external interactions as appropriate.
- The Labeling Operations Manager, Associate reports to the Labeling Operations Manager, Team Lead.
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