Global Labeling Lead

Global Labeling Lead

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Global Labeling Lead to join our diverse and dynamic team. As a Global Labeling Lead at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

What you will be doing:

• Provide regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval. Control the consistency of labeling through review of content across the product family.
• Identify areas of potential non-compliance and supports investigations as needed. Escalate issues pertaining to implementation of core labeling content (Company Core Data Sheet (CCDS, Reference, or Master labels) into product labeling to ensure compliance to regulations and standard processes. Identify potential non-compliance and supports investigations as needed.
• Lead and facilitate the global/regional labeling working groups to support the development of core and major regional labeling.
• Provide regulatory expertise and guidance for the development and submission of European labeling components. Control the consistency of European and ROW labeling content through alignment with the core documents across product families and with all applicable best practices.
• Generate target product label
• Generate USPI for new products and drive revisions for marketed products
• Generate SmPC for new products and drive revisions for marketed products
• Generate initial CCDS

Your profile:

• Bachelor's degree in a scientific discipline or related field.

• Minimum of 8 years of experience in regulatory affairs or labeling within the pharmaceutical or biotechnology industry.

• Strong understanding of global regulatory requirements and guidelines related to labeling.

• Excellent communication and interpersonal skills.

• Ability to work independently and collaboratively in a fast-paced environment.

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 maximize 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 site to read more about the benefits ICON offers.

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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

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.

Are you a current ICON Employee? Please click here to apply