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- 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.
- Why this job: Be part of a team that pushes boundaries in medicine and enhances patient care.
- Qualifications: Bachelor's degree in science and strong experience in regulatory labelling required.
- Other info: Dynamic environment with opportunities for mentorship and leadership growth.
The predicted salary is between 48000 - 72000 £ per year.
Overview
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. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.
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, who are either already part of a CCDS-WT (or for development (pipeline) will later form a CCDS-WT) to develop labelling strategies for new development (pipeline) products.
- Review, as required, other proposed internal or external (e.g. as requested by a Regulatory Authority) changes to local/regional product prescribing information.
- As required, 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 in Marlow 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 in Marlow
✨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 practising your responses to common questions. But don’t just memorise; be ready to discuss how your experience aligns with their values of teamwork and innovation.
✨Tip Number 3
Showcase your passion for making a difference in patients' lives. Share stories from your past roles that highlight your commitment to life and integrity—this will resonate with their mission.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in being part of the KKI team.
We think you need these skills to ace Global Labelling Strategist - Associate Director in Marlow
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Global Labelling Strategist role. Highlight your experience in regulatory labelling and any relevant projects you've worked on. We want to see how your background aligns with our mission to push the boundaries of medicine.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how you embody our values of teamwork, commitment to life, innovation, and integrity. Let us know how you can contribute to making people smile.
Showcase Your Skills: Don’t forget to highlight your leadership and communication skills. As a Global Labelling Strategist, you'll need to articulate complex concepts clearly. Share examples of how you've successfully led teams or managed projects in the past.
Apply Through Our Website: We encourage you to apply through our website for the best chance of being noticed. It’s the easiest way for us to keep track of your application and ensure it gets to the right people. Plus, we love seeing candidates who take that extra step!
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 effectively communicated complex concepts to diverse teams and stakeholders.
✨Prepare for Complex Questions
Expect to face questions that require you to articulate and defend complex labelling concepts. Practise explaining these concepts clearly and concisely, as this will demonstrate your ability to communicate effectively with both technical and non-technical audiences.
✨Demonstrate Leadership and Mentoring Experience
As a potential mentor for junior staff, be ready to discuss your leadership style and any mentoring experiences you’ve had. Share how you’ve supported team members in their development and how you approach training on labelling requirements.
