Job Title:
Global Labeling Strategist
Location:
United States (Remote)
Job ID:
2025-118079
Department:
Regulatory Affairs (ICON Strategic Solutions)
Job Type:
Full-Time, Remote
Application Contact:
Name: Kala Murphy
Message Option: Send a message via job platform
Other Roles: View other roles by Kala
Job Description:
About ICON:
ICON plc is a leading global provider of outsourced development and commercialisation services to the pharmaceutical, biotechnology, and medical device industries. ICON offers innovative solutions and supports clients with clinical development processes.
Key Responsibilities:
Lead the labeling development strategy across cross-functional teams based on target product profiles, competitor review, regulations, and development data.
Create and maintain the target product profile for one asset from Phase 2 to the registrational phase, including new indications for registered assets.
Develop and maintain the Core Company Data Sheet and collaborate with Labeling Operation Manager on the global labeling implementation plan.
Support the US affiliate in the creation and maintenance of USPI (United States Prescribing Information).
Coordinate global labeling impact assessments, including queries from Health Authorities (HA) or internal requests for local label updates in post-marketing.
Lead the Labeling Working Group (LWG) and Global Labeling Committee (GLC) to endorse proposals.
Establish and maintain processes related to labeling development activity.
Qualifications & Experience:
Education: Bachelor’s Degree required.
Experience: At least 5 years of experience in global labeling strategy (development and post-marketing).
Skills:
Experience with biologic products, medical devices, and combined products.
Strong understanding of labeling processes and interfaces across clinical development, medical affairs, pharmacovigilance, regulatory, and supply chain.
Knowledge of US, EU, and Japanese labeling templates and eCTD dossier sections.
Familiarity with health authority websites (FDA, EMA) for label precedents and regulations.
Proficiency with electronic tools like Dr Evidence, Doc Label, Adobe Acrobat Pro, Veeva Vault, and other quality control tools for labeling.
ICON Employee Benefits Include:
Generous annual leave
Health insurance options for you and your family
Competitive retirement savings plans
Global Employee Assistance Programme (TELUS Health)
Life assurance
Country-specific optional benefits, such as:
Childcare vouchers
Bike-to-work schemes
Discounted gym memberships
Subsidized travel passes
Health assessments
More information: ICON Benefits Overview
Diversity & Inclusion Commitment:
ICON is committed to providing an inclusive, diverse, and accessible environment for all candidates. We uphold equal employment opportunities and ensure a workplace free from discrimination.
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