Responsibility:
? Initiation and “build” of Henlius Artwork Requests (PARs), assuring all required information, specifications and/or supportive documentation is available for plants to execute the production of product Labeling related packaging components.
? Negotiating Artwork Change Control logistics across multiple Henlius departments (marketing, regulatory, MF, SCM, etc) and external suppliers to assure Regulatory timelines for Implementation are met and that product supply is not interrupted.
? Tracking Artwork, Key Performance Indicators (KPIs) (e.g. volume, timelines, and/or quality metrics) for assigned projects.
? Retrieve documents and/or generate reports in response to queries from Regulatory Agencies (e.g. inspections) or Assistant General Counsel (e.g. product litigation cases related to Labeling in distribution).
? Evaluates content of Labeling updates and raises potential issues to minimize impact on schedules.
? Upon receipt of final draft Artwork, reviews proofreading report and resolves any technical formatting questions or errors; assures necessary proofreading of final printed Artwork against EC is completed using appropriate tools; escalates any issues, questions or errors within ARTWORK & LABELING IMPLEMENTATION.
? Leads teams in development and revisions of relevant artwork management SOPs.

Requirements:
? Bachelor’s degree or above, major is not limited.
? 6–8 years related work experience (at least 2-3 years of which are preferred to have been in a Labeling Artwork Change Control & Implementation Management).
? Must be familiar with Biopharmaceutical Regulatory environment and cGMPs associated with manufacturing, packaging & distribution processes as well as a basic understanding of Artwork & Labeling regulations and controls.
? Must be able to collaborate with cross-functional teams, negotiate across globally and local distributed affiliates and manufacturing site personnel, and communicate across multiple levels of the organization in a clear professional manner.
? Solid PC business software skills including document authoring, spreadsheet, database management, and presentation applications are required.
? Strong written and verbal communication skills required.
? Strong English language skills are required of non-native English speaking colleague to enable global interactions, and Chinese language is required too.
? Strong demonstrated project management and organizational skills.
? Attention to detail and ability to research and respond to audit/inspection queries.

上班地址：宜山路1289号