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Global Labelling Strategist - Associate Director
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- Full-time
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Global Labelling Strategist - Associate Director

Kyowa Kirin International -
Marlow

Apply Now

Job details

Permanent | Full-time

Qualifications

Bachelor's degree
Leadership
Communication skills
Negotiation

Full job description

Overview:

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

Responsibilities:

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

Qualifications:

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.

Apply Now

Refine Your Search

support associate jobs in thatcham, brk

Global Labelling Strategist - Associate Director

18hr Sales Assistant, Rodd & Gunn- Camp Hopson

Sales Support Administrator

Associate Researcher (Age Friendly Oxford)

Business Operations Associate

VodafoneThree - Associate Accountant - Retail Property

Associate Sys Admin - Compute

Ops Support (Engineer)-Associate Analyst Level

Associate Network Analyst

Junior Infrastructure Engineer (Associate)

Laboratory Technician

Junior Commercial Advisor

JUNIOR SALES ADVISOR

Associate GP Dean

Loss Prevention Officer

Application Analyst- (Associate Level)

30HR KEYHOLDER

Retail Sales Advisor - Farnborough

Systems Administrator (Associate Level)

Arrears & Collections Associate

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