上海招聘

I. Job function
The Clinical Supplies Manager has demonstrated experience in performing the activities required to provide leadership and support in the planning, development, and execution of clinical supply chain activities and the ability to drive cross-functional deliverables and manage activities of supply partners and functions (e.g. packaging and distribution, depots, logistics). The CSM is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials. The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise. .

II. Description
Catalent Clinical Supplies Project Manager will consult with client, CRO, Packager, Logistics and IRT as necessary to lead or assist the following as required:

? Understand and translate clinical study protocol requirements into demand for drug product within a clinical study
? Use simulation tools and supply chain expertise to provide decision in support of the design of optimized, lean supply chains for individual studies or programs
? Create initial study drug projections and supply plan for clinical supply needs throughout life of study including multiple drug campaigns and appropriate drug strategies
? Assist in re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrollment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans
? Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug
? Provide input to IRT specification design. Recommend IRT threshold levels and optimizes as required to make efficient use of clinical supplies while avoiding stock outs at study sites
? Works with IRT in creation of system specifications (URS) associated with supply algorithms
? Act as Unblinded Study Drug Manager in testing of IRT system (UAT) and throughout life of the study
? Monitor and oversee Warehouse and Depot drug levels within IRT throughout study.
? Establish reports within IRT (blinded / unblinded) that will be required to monitor/track drug usage and drug forecasting throughout project life
? Manage drug supply quantities for distribution to designated Warehouses and Depots throughout study
? Assist in the provision of budget estimates in support of quotations for clients
? Coordinate with client and packager to forecast, plan and scheduling of packaging campaigns and drive timeline to desired deliverable
? May provide support of training of other Project Managers in aspects of clinical supply management
? May provide input in development / improvement of existing business processes and contribute to the revision or development of associated training materials
? May participate in Business Development activities to grow the business

III. Position Requirements

Reports to: CSM Director or Manager (also have dotted report line to site/region PM head)

Supervises: None

Education or Equivalent: Bachelor's degree in a science, supply chain or related discipline
6+ years of relevant industry experience with at least 4 years in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle.

Knowledge/Skills Requirements:

? Bachelor's degree in a science, supply chain or related discipline
? 6+ years of relevant industry experience with at least 4 years in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle
? Experience in supply tracking requirements and systems
? Experience in the use of forecasting tools.
? Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management
? Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR), and local GSP (goods supply practice) country basis may applicable.
? Working knowledge of global supply labeling requirements
? Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical supply
? Strong knowledge in IRT technology as it relates to supply chain management
? Skilled in client relationship management and ability to influence customer demand
? Excellent interpersonal skills and problem solving/decision making skills- results oriented.
? Extensive experience of using MS Office programs, with a particular aptitude for MS project and Excel.
? Strong communication skills both written and verbal
? Fluent in both English and Mandarin

Catalent Overview

We are a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development to patient.
With over 85 years of experience in the industry, Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. We became a publicly traded company (NYSE: CTLT) in 2014 and have grown to become a vibrant community of more than 11,000 employees supporting over 7000 products for over 1000 customers all around the world. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.
Currently, Catalent has invested in two facilities in Shanghai, China, located in Waigaoqiao FTZ and Pudong Tangzhen, is near by China’s Zhangjiang Pharma Valley area. The two clinical supply centers will work together to provide a comprehensive range of clinical supply services to clients in China, Asia Pacific and around the world.

Catalent. More products. Better treatments. Reliably supplied.™

For more information please visit our website ****************


康泰伦特概览

我们是临床研发和给药技术的全球领导者，从药物研发，商业化生产到全球服务，我们的技术和服务贯穿于产品的整个生命周期，配方前期研究到生产供应的每一个阶段，我们都能提供完善的方案服务，助力提供更好的产品疗效，让每个人的生活更健康，更精彩。
康泰伦特拥有85年的行业服务经验，每年支持我们的合作伙伴推出200+新产品，超过700亿的年产量。康泰伦特是一家朝气蓬勃的公司于2014年上市并发展成为在全球拥有11,000名雇员，为全球1000多家客户提供7000多款产品。在康泰伦特我们的核心价值观是患者***，在全世界范围内，运用专业知识和先进技术和客户合作提高和改善患者生活。
目前，康泰伦特已在中国上海投资了两家临床供应中心，分别位于外高桥保税区和毗邻张江药谷的浦东唐镇，满足客户国内外临床试验的差异化需求。两家临床供应中心将共同协作为中国、亚太以及全球客户提供全面广泛的临床供应服务。

康泰伦特。更多的产品。更好的治疗。可靠地供应。™

获取更多信息请浏览公司官网 ****************