At a Glance
- Tasks: Lead labelling strategies and collaborate with experts to create impactful product information.
- Company: Join Kyowa Kirin, a forward-thinking pharmaceutical company dedicated to making a difference.
- Benefits: Inclusive culture, career development opportunities, and a chance to make a real impact.
- Other info: Dynamic environment with opportunities for mentorship and leadership.
- Why this job: Be part of a team that pushes boundaries in medicine and improves lives.
- Qualifications: Bachelor's degree in science and strong experience in regulatory labelling.
The predicted salary is between 60000 - 80000 £ per year.
At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity.
Job Purpose: Global Labelling Strategists act as Global Labelling Leads (GLLs). GLLs work cross-functionally with Subject Matter Experts (SMEs) to develop labelling strategies and then to ensure that Company Core Data Sheets (CCDSs), for assigned marketed products, or development CCDSs (dCCDSs), for assigned development (pipeline) products, are created and maintained in alignment with agreed labelling strategies.
Responsibilities:
- Collaborate with SMEs to develop labelling strategies for new development (pipeline) products.
- Review, as required, other proposed internal or external changes to local/regional product prescribing information.
- Support review of proposed product packaging or patient information.
- Articulate and defend complex labelling concepts to stakeholders, including Regulatory Authorities.
- Mentor junior staff or manage staff, their development and training, as required.
- Support or deputise for the Global Head of Labelling, as appropriate.
- Lead and support process improvements when operational or strategic issues are identified.
- Keep abreast of competitive intelligence and changes in regulatory requirements and environment and assess impact.
- Labelling Operational activities (including systems to achieve sub-function ‘labelling’ requirements).
- Training regulatory and cross-functional staff on labelling requirements.
- Audit or inspection attendance, preparation, follow-up etc. with regards to CCDS and labelling management.
Qualifications:
- Bachelor's degree (science discipline preferred). Further relevant qualification desirable.
- Strong experience in the pharmaceutical industry including substantial working knowledge and experience of regulatory labelling in a senior role.
- Ability to understand regulatory and technical concepts and requirements.
- Prior experience with assessing change controls.
- High degree of maturity with good leadership and management skills.
- Excellent negotiation, verbal and written communication and interpersonal skills.
- Ability to understand and present more complex scientific arguments.
Kyowa Kirin International is an equal opportunities employer. No agencies please.
Global Labelling Strategist - Associate Director employer: Kyowa Kirin International plc.
Contact Detail:
Kyowa Kirin International plc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Labelling Strategist - Associate Director
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Kyowa Kirin. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s values and mission. Show how your experience aligns with their commitment to life and innovation. We want to see that you’re not just a fit on paper!
✨Tip Number 3
Practice articulating complex labelling concepts clearly. You might need to explain these to stakeholders, so being able to break them down will set you apart from the competition.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining the team at Kyowa Kirin.
We think you need these skills to ace Global Labelling Strategist - Associate Director
Some tips for your application 🫡
Show Your Passion for Medicine: When writing your application, let your enthusiasm for the pharmaceutical industry shine through. We want to see how you connect with our mission of making people smile and pushing the boundaries of medicine.
Tailor Your Experience: Make sure to highlight your relevant experience in regulatory labelling and any leadership roles you've held. We’re looking for candidates who can articulate complex concepts, so don’t shy away from showcasing your skills in this area.
Be Clear and Concise: Keep your application straightforward and to the point. Use clear language to describe your achievements and how they align with our values of teamwork, commitment, innovation, and integrity. We appreciate a well-structured application!
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Kyowa Kirin International plc.
✨Know Your Labelling Strategies
Make sure you brush up on the latest labelling strategies and regulatory requirements in the pharmaceutical industry. Being able to discuss specific examples of how you've developed or implemented these strategies will show your expertise and commitment to the role.
✨Showcase Your Collaboration Skills
Since this role involves working cross-functionally with Subject Matter Experts, be prepared to share examples of successful collaborations from your past. Highlight how you’ve navigated complex discussions and built relationships to achieve common goals.
✨Prepare for Complex Questions
Expect to articulate and defend complex labelling concepts during the interview. Practice explaining these concepts clearly and concisely, as well as how you would handle questions from stakeholders or regulatory authorities.
✨Demonstrate Leadership and Mentoring Experience
As a potential Associate Director, showcasing your leadership skills is crucial. Be ready to discuss your experience in mentoring junior staff and managing teams, along with any process improvements you've led in previous roles.