At a Glance
- Tasks: Lead labelling strategies and collaborate with experts to create impactful product information.
- Company: Join Kyowa Kirin, a caring and innovative pharmaceutical company.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic environment with mentorship opportunities and career advancement.
- Why this job: Make a real difference in patients' lives while pushing the boundaries of medicine.
- Qualifications: Bachelor's degree in science and strong experience in regulatory labelling.
The predicted salary is between 60000 - 80000 € per year.
Location: Marlow UK or any of our EMEA offices
WE PUSH THE BOUNDARIES OF MEDICINE. LEAPING FORWARD TO MAKE PEOPLE SMILE
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.
Key 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
Position Requirements
- 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.
Global Labelling Strategist - Associate Director in Marlow employer: Kyowa Kirin
At Kyowa Kirin International, we are dedicated to pushing the boundaries of medicine while fostering a culture of teamwork, innovation, and integrity. Located in Marlow, UK, our inclusive environment not only prioritises patient care but also offers exceptional growth opportunities for employees, including mentorship and cross-functional collaboration. Join us to make a meaningful impact in the pharmaceutical industry and be part of a team that truly cares about making people smile.
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; think about how your experiences align with their values of teamwork and innovation.
✨Tip Number 3
Showcase your passion for making a difference in healthcare. Share stories that highlight your commitment to life and integrity during interviews to resonate with their mission.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed and shows you’re serious about joining the team at Kyowa Kirin.
We think you need these skills to ace Global Labelling Strategist - Associate Director in Marlow
Some tips for your application 🫡
Show Your Passion:When writing your application, let your enthusiasm for the role shine through. We want to see how much you care about making a difference in the pharmaceutical industry and how our values resonate with you.
Tailor Your CV:Make sure to customise your CV to highlight relevant experience that aligns with the Global Labelling Strategist role. We love seeing how your background fits into our mission of pushing boundaries and delivering life-changing solutions.
Be Clear and Concise:Keep your application straightforward and to the point. We appreciate clarity, so make sure your skills and experiences are easy to understand. Avoid jargon unless it’s necessary to showcase your expertise.
Apply Through Our Website:Don’t forget to submit your application 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
✨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. Prepare to discuss your experience in mentoring junior staff and managing teams, including any specific challenges you faced and how you overcame them.
