Market Coordinator

Pennsylvania  ‐ Onsite
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Description

RESPONSIBILITIES:
  • Colleague fundamentally performs the Market Coordinator role on behalf of WRS and is the central point of contact in Regulatory for the plants/artwork centers.
  • The colleague will be responsible for initiation of artwork requests and coordination of logistics across multiple departments to assure regulatory timelines for Artwork implementation are met and that product supply is not interrupted.
  • Colleague is responsible for coordinating the change control logistics for implementation of final printed labeling content into secondary packaging components.
  • Colleague liaises with center disciplines to gather and/or coordinate receipt of necessary information (eg editor's copy and local or regional requirements) for labeling artwork initiation and implementation.
  • Colleague will liaise with GLM function, WRS, and artwork centers to coordinate any unique factors that need to be considered and document agreement on labeling artwork timelines.
  • Colleague will escalate any issues/concerns within ALIM functional line and/or leadership for adjudication as necessary.
  • Initiation and management of Artwork Requests requires the use of electronic artwork and labeling management system and requires the performance of the following activities:
  • Evaluate sites impacted by labeling updates
  • Ensure attributes (system metadata) are correct, and ensure all relevant regulatory documents are included
  • Send artwork requests to all relevant sites
  • Upon receipt of final draft artwork, reviews proofreading report from artwork center and resolve any technical formatting questions or errors
  • Performs any necessary proofreading of final printed artwork against editor's copy using appropriate tools; escalates any issues, questions or errors within ALIM functional line or appropriate Markets for adjudication as needed
  • Evaluate packaging and labeling artwork updates, interpret information and ensure that changes have been applied consistently across products and product lines.
  • Initiate discussions when artwork inconsistencies are discovered.
  • Annotate packaging and labeling artwork using digital tools.
  • Use appropriate judgment and approve or reject packaging and labeling artwork.
  • Provide clear explanation to artwork center for accurate re-creation of artwork when needed.
  • Negotiate proofreading due dates with customers when necessary.
  • Communicate with Manufacturing on status of Artwork Requests to ensure agreed upon timelines are met.
  • Communicate with Regulatory Strategy on labeling artwork timelines as needed.
  • Participate on departmental projects and cross-functional teams, as assigned.
  • Evaluate content of labeling updates to assess impact on packaging artwork.
  • Use biopharmaceutical packaging and artwork knowledge, in combination with Trade Dress Style Guides and other guidelines while collaborating with manufacturing artwork centers to create accurate packaging Editor's Copies.
  • Identify appropriate Market Approvers for packaging artwork and electronically route for approval using electronic life cycle management system
  • Interact and follow up with all Market Approvers, as needed, and address regulatory content issues as they arise during the approval process.
  • Work with minimal direct supervision.
  • Initiate, manage and track any necessary rework
  • Route artwork requests and/or Artworks for approval to list of stakeholders; monitor progress and follow up as needed with appropriate artwork centers or WRS to assure agreed timelines are met
  • Track and communicate final approved labeling to list of relevant departments and stakeholders following final market review and signoff
SKILLS:

SKILLS/EDUCATION:
  • Document management tools supporting storage, retrieval, life cycle management and tracking of labeling and/or artwork for secondary packaging components.
  • Bachelor's degree in an appropriate discipline, plus 4-6 years related work experience.
QUALIFICATIONS:
  • Must be able to collaborate with cross-functional teams, negotiate across globally distributed affiliates and manufacturing site personnel, and communicate across multiple levels across the organization in a clear professional manner
  • Must be able to work under pressure of tight timelines, apply judgment in ambiguous business situations and appropriately escalate issues/potential impacts
  • Strong demonstrated project management and organizational skills
  • In depth knowledge of manufacturing and site processes/requirements
  • Must have capacity to solicit input in ambiguous business situations, resolve conflicting inputs and make appropriate business decisions
  • Attention to detail and ability to research and respond to audit/inspection queries
Start date
n.a
From
Synectics
Published at
27.01.2016
Project ID:
1059452
Contract type
Freelance
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