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Labeling Operations Manager, Associate Consultant
ClinChoice
Contract type
Ongoing
Work mode
Remote
Experience
3 years
Job description
The Labeling Operations Manager (LOM), Associate provides operational and project management support for the creation and update of labeling documents such as Core Data Sheets, US Package Inserts, and EU Summary of Product Characteristics, supporting non-complex products and projects.
At a glance
- Work mode
- Remote
- Languages
- English – fluent
What you'll do
- Support the review and delivery of labeling documents and their associated Patient Labeling Documents for non-complex products and projects.
- 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 and follow applicable SOPs.
- 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 and 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.
What we're looking for
- Bachelor's degree required, preferably in a science or life sciences-related field.
- 0-2 years of practical experience.
- Excellent written and verbal communication skills.
- Complete fluency in English.
- Proven strength in logical, analytical and writing ability.
- High attention to detail.
- Excellent computer skills and proficiency with Microsoft Word and similar applications.
- 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.
- Ability to liaise with stakeholders using effective means of communication.
- 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.
- Ability to prepare submission-ready documents.
Your team
Labeling Team
The LOM, Associate reports to the Labeling Operations Manager, Team Lead.
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