天津招聘

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.

    复宏汉霖（*******）是一家国际化的创新生物制药公司，旨在为全球患者提供质高价优的创新生物药，产品覆盖肿瘤、自身免疫性疾病等领域。自2010年成立以来，公司以全球联动、整合创新为产品开发理念，在中国上海、中国台北和美国加州均设有研发中心，具备了协同增效的突出优势。复宏汉霖主要的产品开发策略是仿创结合，从生物类似药起步，逐步开发创新型单抗产品，结合自主开发的抗PD-1和PD-L1单抗，在国内率先推出免疫联合疗法，前瞻性布局了一个多元化、创新单抗及肿瘤免疫联合疗法管线，打造出研究、开发、商业化生产的综合性生物医药全产业链平台。

    截至目前，复宏汉霖已有1个产品成功上市，2个产品获得中国新药上市申请受理，1个产品获得欧盟营销授权申请受理，10个产品、8个联合治疗方案在全球范围内开展20多项临床试验。其中，公司首款重磅产品汉利康？（利妥昔单抗注射液）于2019年2月获国家药监局新药上市注册批准，成为中国***获批上市的生物类似药。HLX03（阿达木单抗注射液）与HLX02（注射用曲妥珠单抗）已获国家药监局新药上市申请受理，现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验，成为国内***开展国际多中心3期临床研究的生物类似药，并于2019年6月获欧洲药品管理局营销授权申请受理。此外，公司已陆续就HLX10（抗PD-1单抗）与自有产品HLX04（贝伐珠单抗生物类似药）、HLX07（抗EGFR单抗）以及化疗联用开展多项肿瘤免疫联合疗法，在全球范围内开展多个临床研究。