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- Tasks: Lead global labeling efforts and ensure compliance in drug development.
- Company: Join ICON, a leading healthcare intelligence and clinical research organisation.
- Benefits: Enjoy competitive salary, health insurance, flexible benefits, and work-life balance.
- Why this job: Make a real impact on innovative treatments while working in a diverse team.
- Qualifications: 8+ years in regulatory affairs with strong communication skills.
- Other info: Inclusive culture focused on talent development and career growth.
The predicted salary is between 70000 - 90000 £ per year.
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 support 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 with regulations and standard processes.
- 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.
- 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
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.
Global Labeling Lead - Homebased in the UK in Reading employer: ICON
Contact Detail:
ICON Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Labeling Lead - Homebased in the UK in Reading
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend relevant events, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching ICON and understanding their values and mission. Tailor your responses to show how your experience aligns with their goals, especially in regulatory affairs and labeling.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your answers. Focus on articulating your experience in regulatory compliance and teamwork.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in joining our diverse team at ICON.
We think you need these skills to ace Global Labeling Lead - Homebased in the UK in Reading
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experience that match the Global Labeling Lead role. Highlight your regulatory affairs experience and any relevant projects you've worked on. We want to see how you can contribute to our mission!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background aligns with our values at ICON. Let us know what excites you about shaping the future of clinical development.
Showcase Your Communication Skills: As a Global Labeling Lead, strong communication is key. In your application, demonstrate your ability to convey complex information clearly. Whether it's through your CV or cover letter, let us see your interpersonal skills in action!
Apply Through Our Website: We encourage you to apply directly through our careers site. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, you’ll find more info about the benefits we offer!
How to prepare for a job interview at ICON
✨Know Your Regulatory Stuff
Make sure you brush up on global regulatory requirements and guidelines related to labelling. Being able to discuss these confidently will show that you’re not just familiar with the basics, but that you truly understand the complexities of the role.
✨Showcase Your Experience
Prepare specific examples from your past 8 years in regulatory affairs or labelling. Highlight situations where you identified non-compliance or led labelling working groups. This will demonstrate your hands-on experience and problem-solving skills.
✨Communicate Clearly
Since excellent communication is key for this role, practice articulating your thoughts clearly and concisely. You might want to do a mock interview with a friend to get comfortable discussing complex medical data and labelling components.
✨Emphasise Teamwork
ICON values collaboration, so be ready to discuss how you’ve worked independently and as part of a team in fast-paced environments. Share examples that highlight your interpersonal skills and ability to facilitate discussions within diverse teams.