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Labeling Operations Director - United Kingdom  

Amgen (company)


Posted on : 01 May 2017

Project Description

Principal responsibilities include, but are not restricted to:
  • Strategy & Execution
  • Accountable for the strategic leadership and operational oversight of  product labelling development, execution and compliance in the regionLabeling operational strategy, policy & 5 year vision
  • Drive labeling transformation and business excellence
  • E2E label governance, process and system owner for the region:Drive affiliate alignment and ensure compliance to regulations and labeling transformation globally
  • Ensure business excellence and drive labeling transformation
  • Direct end to end label process and system globally 
  • Develop global sourcing strategy to deliver regional labeling vision and optimal resource utilizationSelect, assess and manage performance of vendors
  • Partner and align with regional operations / artwork teams

Responsibility for budget management
  • Provide strategic advice and lead complex initiatives, projects or teams on behalf of Global Labeling
  • Establishes strategy for Corporate Translational services and is owner of company Translation Memory
  • Governance
  • Establish and direct a robust governance structure for regions including a timeline waiver processChair of regional / local labeling governance body
  • Approve / sign off timeline waiver requests globally
  • Advise the appropriate governance body on any potential labeling issues
  • Overall accountability for the consistent and timely implementation of label changes to communicate company core labeling position and product information:
  • Across all company  product lines, marketed, development and Biosimilars
  • Assure compliance to international & multiple national regulations
  • Ensure corporate compliance with labeling policies and Standard Operating Procedures  involving end to end label process

Collaboration and Partnerships
  • Initiate and build effective partnerships across global, regional, local and functional organizations to drive end to end labeling process excellence & compliance to (divergent) regional regulatory timelinesPoint of contact for all labeling matters in the regions across the full product portfolio e.g., first point of contact for General Manager regarding Labeling
  • Establish credible relationships across all organizational levels including senior management
  • Develop relationships with external industry bodies to surface and build an industry leading approach to labeling
  • Apply deep knowledge of global labeling requirements,Reference label/dependent label relationships
  • Awareness of evolving Labeling related regulations in region and help shape the company position to meet requirements
  • Oversight and collaboration with global labeling vendors to set and maintain high performance and compliance standards
  • Build and maintain a world class end to end labeling process, systems, tools, data and document management
  • Build a global translation strategy, and successfully deploy a translation tool and memory

  • Accountable for succession planning for team providing regional support
  • Provide mentoring & direction to regional and local team members as appropriate.
  • Managing resource and workload distribution across region 

Knowledge and Skills Required
  • Advanced / highly developed knowledge of labeling regulations with particular focus on the regulatory environment in global markets
  • Ability to apply deep knowledge of regional labeling requirements, in particular label reference dependency
  • Understanding the impact of emerging regulatory requirements and there implications for the company.
  • Proven ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
  • Ability to take initiative and drive results
  • Previous experience working in industry in support of Global Labeling, Regulatory, Engineering or Quality Management/Quality Engineering
  • Time and project management skills
  • Accomplish business results through teams
  • Tolerance for ambiguity
  • Influencing, negotiation and decision making skills
  • Accountable for hiring and succession planning of staff
  • Demonstrated ability to accomplish business results through teams
  • Analytical thinking, demonstrated ability to anticipate and solve problems by providing solutions prior to escalation of issues to management
  • Strong collaboration, presentation, communication, interpersonal, and leadership skills
  • Ability to apply continuous process improvement methodologies

Education & Experience (Basic)
  • Degree (BSc, MSc, PhD) in Life Sciences
  • Extensive related experience
  • Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Education & Experience (Preferred)       
  • Previous experience in managing a global labeling operations team
  • Previous experience working in industry in support of global labeling, artwork and operations
  • Previous experience working with combination products and/or Human Factors Engineering
  • Demonstrates leadership attributes
  • Excellent interpersonal skills
  • External visibility (e.g. through industry committees)
  • Experience in vendor management
  • Fluent in English (oral and written)
  • Organizational expert within defined subject area