BrightOwl Loader Loading

Labelling Operations Manager Uxbridge 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.

Locations

United Kingdom Uxbridge

Find a Job Find Candidates

Similar Jobs

More jobs from Amgen

Other jobs in United Kingdom

Other jobs in Uxbridge

Other jobs from Amgen in Uxbridge

Other similar job in Uxbridge

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like