Global Labelling Strategist - Associate Director

at Kyowa Kirin International plc

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.

No agencies please.