Associate Analyst

Role & responsibilities

• Custodian of the packaging design and layout for all products
• Provides relevant source data for the Change Order/ Change Awareness notification
• Annotate the PDFs as per the respective Regulatory source content (word format)
• Clarify on need basis with the respective stakeholders, i.e. Labelling Lead, Artwork Coordinator, Market or Site
• Adherence to GSK artwork production standards and Standard Operating Procedures
• Identifies and engages other individuals who need to be involved in the review and approval of a Change Order, in accordance with any local procedures and requirements
• Participates in the review of the change on its viability on behalf of the market
• For changes initiated by the site: Reviews comments and authorizes the Change if required
• Ensures all critical checks have been carried out in accordance with the artwork checklist
• Approves the Change, referring to Regulatory Approved Labelling in Country Prescribing Information / Local Datasheet from Regulatory Vault
• Reviews and approves the new artwork in the Change Order(s) against Regulatory Approved Labelling in Country Prescribing Information /Local Datasheet and any supporting documents
• Responsible to re-prioritise the changes based on the business requirements
• Co-ordinates market activities/approvals as necessary throughout the lifetime of the change
• Ensure that all design and readability guidelines are adhered to across the full range of packs.
• Checks and confirms that artwork created matches authorized briefs / change orders covering multiple types of pack components, languages and formats
• To ensure that the relevant markets and sites approve the artworks prior to the Global Labelling approval or where acting on behalf of the LoC approve the change in line with the project and schedule requirements
• Adherence to regulatory and quality compliance requirements
• Adherence to agreed schedules for artwork production
• Be part of weekly Planning meetings to understand upcoming changes
• Responsible for working with Leads/Operations Manager to identify issues and resolve accordingly
• Responsible for maintaining high standards and working within agreed service level agreements
• Ensures that data integrity and accuracy is maintained throughout the proof-reading (review of the artworks) / amendment stages
• Implements the principles of Operational Excellence and Lean Sigma to recommend and bring about continuous improvement
• Monitors progress of artwork creation and ensures delays or issues are rectified or escalated to the appropriate level of management, and customers are kept informed of progress
• Ensure delivery of PBRERs, Addendum to clinical Overview (ACOs) and Line Listings are delivered as per the schedule

Preferred candidate profile