[Hiring] Labeling Operations Specialist @Fortrea

Role Description

The Labeling Operations Specialist (LOS) 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
• Associated Patient Labeling Documents

The LOS is capable of managing a large volume of projects, which can be medium to highly complex. They 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 by:

• Notifying stakeholders to ensure timely production of documents according to internal SOPs and external regulatory requirements.
• Setting clear targets and ensuring Labeling Teams are aware of review and approval timelines.
• Following up with Labeling Team members to keep deliverables on target.

Qualifications

• Bachelor’s degree in a science or life sciences required
• 2-4 years experience in a regulated environment; pharmaceutical labeling experience preferred
• Knowledge of global/regional regulatory guidelines and requirements
• Excellent written and verbal communication skills
• Complete fluency in English Language
• Proven strength in logical, analytical and writing ability
• Demonstrated project management skills and attention to detail
• Identifies and resolves problems in a proactive manner
• Strong knowledge/understanding of the principles and concepts of the discipline

Requirements

• Ability to assess and manage project timelines
• Ability to multi-task, prioritize and manage multiple projects
• Demonstrates appropriate decision making including issue escalation to the Global Labeling Lead (GLL) and other stakeholders
• Works under general supervision and performs assignments using established procedures
• Participates and contributes as a team member
• Ability to liaise with stakeholders using effective means of communication
• Clear and effective written and verbal communication skills
• Able to work in ambiguous situations as part of a Work Team
• Uses own judgment to modify standard methods and techniques when necessary

Benefits

• Available for regional or global travel 5-10% of the time including overnight stays as necessary
• Office environment or remote work options