What are the responsibilities and job description for the Director Global RA Labeling position at Infotree Global Solutions?
Objective / Purpose:
Accountable for the development and implementation of labeling content and strategy for multiple products at various stages of drug development. Responsible for updates to or creation of new Target Labeling Profiles (TLP), Core Company Data Sheets (CCDS), US Prescribing Information (USPI), and EU Summary of Product Characteristics (SmPC).
Key Responsibilities:
Management of Labeling Cross-Functional Teams
· Lead labeling cross-functional teams, promoting collaboration and driving alignment between labeling strategies and content.
Strategic Leadership
· Provide strategic guidance to labeling leads, ensuring alignment with client processes like Future Fit and Submission Excellence.
Labeling Documents Authoring, Submission, and Negotiations
· Independently author or revise TLP, CCDS, USPI, and/or EU SmPC for assigned products, securing approval from relevant stakeholders.
Management of Local Exceptions and LOC Interactions
· Oversee the process of aligning local labeling with CCDS, evaluating exceptions and deferrals.
Escalation Process and Stakeholder Management
· Appropriately escalate issues to Global Labeling management and the Global Regulatory Lead (GRL), proposing risk mitigation strategies.
Precedent Search and Labeling Trends
· Conduct precedent searches, analyze competitor labeling, and monitor health authority requests and trends to shape labeling strategies and language.
Vendor Management
· Oversee external vendor activities to ensure timely delivery, quality standards, and alignment with labeling objectives.
Continuous Improvement
· Contribute to continuous labeling process improvement, identifying optimization opportunities to enhance efficiency and accuracy.
Education & Competencies:
Education:
· BSc degree required, BA acceptable.
· Advanced scientific degree (MSc, PhD, or PharmD) preferred.
Experience:
· 10 years of pharmaceutical industry experience, with a minimum of 8 years of labeling experience or a combination of 6 years regulatory or related experience.
Job Type: Contract
Pay: $100.00 - $150.00 per hour
Expected hours: 40 per week
Experience:
- pharmaceutical: 10 years (Required)
- Labelling: 8 years (Required)
- Regulatory: 8 years (Required)
Work Location: In person
Salary : $100 - $150
