The Labeling Operations Sepecialist (LOS) provides operational support for the initial creation and relevant updates to labeling documents including the Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized
Procedures, and their associated Patient Labeling Documents. The Labeling Operations Manager, Senior Associate is capable of managing a large volume of projects, these projects can be medium to highly complex.
The LOS will be knowledgeable of labeling guidance and policies related to technical/formatting (e.g. QRD template, PLR format) and will raise awareness of important factors to consider when revising the label.
The LOS provides project management to the Labeling Team throughout the labeling review and approval process through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets, ensuring that Labeling Teams are aware of the review and approval timelines and following up with Labeling Team members
throughout the process as appropriate so that deliverables remain on target to meet internal and external deadlines.
- Summary of Responsibilities:
- Generate necessary renditions (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate.
- Facilitate document workflow through corporate document repository
- Finalize documents post QC
- Utilize labeling tracking systems and perform system data quality checks.
- Utilize text verification and proofreading tools
- Notify internal stakeholders of the availability of labeling documents.
- Consolidate labeling versions.
- Consolidate comments from Labeling reviewers and Regulatory Authorities.
- Prepare comparison tables for labeling team discussions.
- Edit and format labeling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR).
- Update and maintain the CDS log.
- Manage the document status in document management system
- Notify and communicate with internal stakeholders
- Set clear targets for review and approval timelines for labeling documents using effective project management. Follow up with Labeling Team members to ensure timely review and approval deadlines are met.
- Create SPL for USPIs, partner with key SMEs and notify internal stakeholders of its availability
- Update related labeling documents e.g., for products within a similar class, of different dosage forms, and for generics.
- Provides shadowing opportunity to junior LOM's
- Responsible for ensuring compliance to Company’s submission standards, policies and procedures. Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
- Qualifications (Minimum Required):
- Knowledge of global/regional regulatory guidelines and requirements important.
- Excellent written and verbal communication skills essential.
- Complete fluency in English Language.
- Proven strength in logical, analytical and writing ability essential.
- Demonstrated project management skills and attention to detail required.
- Identifies and resolves problems in a proactive manner.
- Has strong knowledge/understanding of the principles and concepts of the discipline
- Project Management capability and organizational skills:
- Ability to assess and manage project timelines.
- Ability to multi-task, prioritize and manage multiple projects.
- Ability to identify and resolve problems in a proactive manner.
- Demonstrates appropriate decision making including issue escalation to the Global Labeling Lead (GLL) and other appropriate stakeholders.
- Works under general supervision. Performs assignments using established procedures and general instruction on the process and desired outcome
- Participates and contributes as a team member
- Interpersonal and communication skills:
- Ability to liaise with stakeholders using effective means of communication.
- Clear and effective written and verbal communication skills.
- Makes decisions to resolve moderately complex problems in standard situations
- Makes decisions within guidelines and policies
- Able to work in ambiguous situations as part of a Work Team
- Decisions have short-term effect on the delivery of scheduled programs/projects
- Uses own judgment judgment to modify standard methods and techniques when necessary
Technical Skills
- Ability to apply labeling regulatory guidance on formatting requirements.
- High attention to detail.
- Ability to consolidate comments from multiple sources (e.g., emails, meeting minutes).
- Applies technical skills and Work Team knowledge to achieve assigned work on projects/assignments
- May act as a technical resource within own Work Team
- Understands the fundamental business drivers for the company
- Uses this knowledge in own work
- Systems and Document compilation skills, including:
- Must have excellent computer skills and be proficient with Microsoft Word and similar applications.
- Prepare submission ready documents.
- Physical Demands/Work Environment:
- Physical demands: Available for regional or global travel 5-10% of the time including overnight stays as necessary consistent with project needs and office location.
- Work environment: Office environment or remote.
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