Career Category

Quality

Job Description

Job Summary

As part of GLC group, and under the supervision of the Global Labeling Process Management (LPM) Sr. Manager, the LPM Manager supports the LPM team to ensure timely Amgen launches, provide expert labelling knowledge and strategic input to stakeholders for the creation of artwork. The LPM Manager is also the point of contact for their assigned local markets and key contributor in the cross-functional teams established to successfully complete on time submissions to HA, and implementation of commercial artwork upon approval.

Key Responsibilities

Principal responsibilities include, but are not restricted to:

• Apply expert labeling knowledge to collaborate with Local Amgen Affiliates, along with Regional Regulatory Affairs and Operations colleagues, to plan and implement label changes, ensuring compliance with labeling processes.
• Provide process and system support.
• Provide artwork source text and process support as necessary.
• Participate in Labeling Submissions meetings to provide input on labeling processes.
• Provide regional operational support for labeling.
• Support document management of all regional labeling documents, source text, illustrations, and related documents.
• Support the maintenance of business process documentation, including guidance documents.      
• Provide accurate regulatory assessments for Change Control records governing the implementation of labeling changes.
• Maintain a state of inspection readiness for records within the Labeling tool.
• Develop regional package component labels according to regulations and company guidelines
• Establish and execute process to successfully adhere to compliance with regional regulatory labelling requirements.
• Labeling contact person for internal and external audits and inspections
• Apply continuous improvement practices and processes by anticipating problem areas, looking at current processes and developing solutions; escalate issues appropriately.
• Using project management skills to initiate and manage translations for international markets ensuring health authority timelines are met.
• Review and approve master artwork to ensure compliance with approved mock up/text mapping
• Supporting launch of new products and presentations.
• Mentoring/training junior team members and local regulatory, operations staff on End to End Labeling processes & systems as requested by supervisor.

Qualifications

Basic Qualifications:

• Bachelor’s/Master’s degree with minimum 8 years of experience in Labeling

Required Qualifications

• This is an Individual Contributor role that requires the following core competences for the candidate to be successful in this role:

• Previous experience working in industry in support of End to End Labeling Initiatives including global labeling compliance and regional labeling for international (ROW) markets
• Oral and Written Communication and Presentation Skills
• Project Management skills such that candidate can work independently to deliver expected outputs
• Relationship Management
• Influencing, Negotiation and Decision Making Skills
• Extends capabilities by working closely with senior staff/experts within and outside the internal organization
• Previous labelling experience in HA Regulations and International Markets
• Knowledge of labelling regulations and requirements, industry trends and business principles
• Demonstrates leadership attributes, managing individual and complex group projects
• Excellent interpersonal skills with ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
• External visibility (e.g., through industry committees)
• Influencing and negotiation skills
• Time and project management skills
• Ability to take initiative and drive results
• Tolerance for ambiguity
• Proficiency in anticipating and resolving problems
• Strong communication skills (oral and written)

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