Within regulatory affairs and in cross-functional teams, lead the labeling development of one asset, supervise Target Product Label initiative across the portfolio and, when needed, contribute to the labeling strategy of other assets.

• Lead labeling development strategy in cross functional teams based on target product profile, competitor review, regulations, development data and present it to the development governance for endorsement
• Create and maintain target product profile for one asset from phase 2 until registrational phase and for new indication of registered asset(s)
• Create and maintain Core Company Data Sheet and, in partnership with Labeling Operation Manager, global labeling implementation plan
• Support US affiliate in USPI creation and maintenance
• Coordinate global labeling impact assessment of HA or internal queries of local label update in post- marketing, involving:
• Labeling working group (LWG) - Cross functional team which members are identified in function of topics among Development team, Project team, Pharmacovigilance,
• Regulatory leads, Medical affairs, Commercial, Legal representatives, Intellectual property, CMC, supply chain.
• Global labeling committee (GLC) to endorse LWG proposal
• Create and maintain processes related to labeling development activity

• Prior experience in biologic products, medical devices, combined products
• Prior experience in clinical development and/or regulatory affairs environment
• Strong understanding of labeling end-to-end process and interfaces between clinical development, medical affairs, Pharmacovigilance, Regulatory, Quality and Supply Chain to ensure compliance
• Knowledge of US, EU, Japanese labeling templates and labeling sections of eCTD dossier
• Knowledge of health authority websites (in particular FDA, EMA websites) to retrieve label precedents and labeling regulations
• Knowledge of electronic tools such as Dr evidence/Doc label, Adobe Acrobat Pro, Regulatory information management systems, Electronic Document Management System (e.g. Veeva Vault), other tools for labeling quality control (Text Verification Tool).
• Detail oriented and well organized
• Good oral and written English language skills
• Active listening, understanding constraints from other discipline
• Critical thinking: using logic and reasoning to identify the strength and weaknesses of alternative solutions, conclusions or approached to problems
• Active learning: understanding the implications of new information for both current and future problem-solving and decision-making
• Analytical skills: decision taking based on facts and figures rather than on assumptions  Team player who seeks to help and learn from colleagues
• Bachelor’s Degree Required
• At least 5 years of experience in global labeling strategy (development and post-marketing)

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.