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Labelling Operations Manager - United Kingdom  

Amgen (company)


Posted on : 13 May 2017

Project Description

Principal responsibilities include, but are not restricted to:
  • Monitor and triage requests through the BPM tool (LEXA) for timeline waivers and deviations from core or reference label content. 
  • Facilitate communication within Global Labeling to provide labeling advice for Response to Questions (RTQ) for global and regional markets (e.g. Reg Affairs, Artwork)
  • Report, track and advise on bundling of core documents to Labeling Strategists and RA
  • Monitor mid- to long-term planning of upcoming CDS/Global labeling changes and project deadlines to Labeling Strategist and Artwork Center.
  • Provide US, EU and other regional labeling operational support, including formatting, templates, SPL, QC, readability, linguistic review, translations, including translation memory management.
  • Support development of labeling templates for all core labels
  • Support local regulatory by providing guidance in maintaining data in LEXA and documents EPIC, including clarification of processes.
  • Support projects for changes impacting more than one core label, working across Therapeutic Areas and provides global project management coordination
  • Support management of global labeling vendors to ensure established SLA’s are met (e.g. translations, Quality Control checks, etc.)
  • Monitor GRAIL for labeling intelligence updates and communicate to Labeling team
  • Supports US clinical labeling requirements and labeling content statements
  • Support initiatives which involve labeling

Knowledge and Skills:
  • Previous experience working in industry in support of Global Labeling, Regulatory, Engineering or Quality Management/Quality Engineering
  • Accomplish business results through teams
  • Proficiency in anticipating and resolving problems
  • Use of document management tools
  • Understanding the impact of emerging regulatory requirements and there implications for our company.
  • 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
  • Tolerance for ambiguity
  • Proficiency in anticipating and resolving problems
  • Oral and written communication and presentation skills
  • Project management
  • Relationship management

Education and Experience:
  • Degree in pharmaceuticals, natural science or medicine
  • Previous experience working in industry in support of global labeling
  • Project Management
  • Vendor Management
  • Fluent in English (oral and written)
  • Our company is an equal opportunities employer.