宜昌招聘

Position Title: Clinical Trial Manufacturing and Materials Services China Associate

Reporting to: CMC-PM China / Indirect report to Director Global CTMMS - Portfolio Support


Main Purpose and Objectives of Position:
The Clinical Trial Manufacturing and Materials Services China Associate (CTMMS-China Assoc) will partner with a network of internal resources and third party contract organizations to execute clinical trial material activities in China.

The CTMMS-China Associate acts in conjunction with the CTMMS-PM responsible for the compound, and is accountable for implementing clinical trial materials management activities in China. The CTMMS-China Associate partners with the business process owners (BPO) in the development and optimization of the processes for CT supply and labeling, comparator & packaging component sourcing, blinding, randomization, dispensing, global distribution, and returns /destruction, as required for China projects. CTMMS-China Associate provides insight and recommendations into the siting of manufacturing and packaging activities, the material delivery requirements, packaging design and component selection, and provides, as required, technical oversight for packaging and labeling activities. CTMMS-China Associate also ensures compliance with appropriate Lilly procedures and regulatory requirements for clinical trial materials manufactured and packaged in China. Finally, they will provide in country man-in-plan support, as needed, for contract manufacturing, packaging, and distribu-tion.



Key Responsibilities:
? Feasibility and Risk Assessments:
? Determine and communicate with the CTMMS-PM potential risks, limitations, and possible mitigation strategies (where appropriate) associated with the CT material supply for compounds and studies sup-ported.
? Support selecting and qualifying CMOs with the needed capabilities.
? Strategic Planning and Budgeting:
? Advise the CTMMS-PM on strategic options for comparator sourcing, packaging, label design, standardization, distribution, use of Interactive Response Systems (IVRS/IWRS), material pooling, retest dating management, and inventory/resupply management as it relates to China. Will work with CTMMS-PM to contribute to compound level strategies as they apply to China.
? Work with the CTMMS-PM, contract manufacturing & distribution organizations, and clinical study teams to ensure robust supply chain strategies and budgets are developed for the studies they supported by the CTMMS-China Associate.



? Execution and Clinical Study Support:
? Assume responsibility for achieving all clinical trial material milestones in China.
? Interact with the CTMMS- PM and cGMP Contract Manufacturing Organizations (CMOs) to coordinate CTM manufacturing, packaging, labeling, distribution, and supporting activities.
? Provide technical oversight for manufacturing, packaging, labeling, and distribution activities at CMOs including batch record development, execution and shipping documentation preparation. Serve as person in plant to provide oversight and guidance as needed.
? Provide the necessary documentation for packaged and labeled material and ensure on-time QA/QP re-lease.
? Ensure packaging, labeling, and CTMMS inventory and distribution records are maintained.
? Aid in CTMMS issue resolution for contract manufacturing, packaging, and distribution organizations.
? Act as the single point of contact when CTMMS utilizes the recalls and destruction process for clinical trial material in China.

? Process Optimization and Compliance:
? Continuously assess business processes for inefficiencies and improvement opportunities, identify action plans, and implement improvements. Leverage expertise to challenge and change the status quo.
? Review global CTMMS processes and where needed, recommend changes or modifications to support clinical trial material in China.
? Build relationships through interaction with preferred CMOs and CTMMS members to build integrated and efficient processes while ensuring thorough communication.
? Provide input into CMO performance metrics and solicit feedback and suggestions from CMOs, clinical study teams, and affiliate resources to ensure continuous improvement.
? Contribute to regulatory documentation for submissions to enable global clinical trials.
? Document deviations to procedures and help to conduct root cause analyses.
? Work with CTMMS Leadership to provide feedback on root cause(s) of issues and learnings to drive process improvement along with understanding industry trends, new technologies and capabilities within the CT material space.
? Share information and provide coaching and feedback to allow the growth and development of other CTMMS resources.
? Accountable for escalation of issues and counter measures to the CTMMS-PM.
? Accountable for providing updates to CTMMS-PM and customers for key deliverables and communication when customer impact will occur.
? Contribute to risk assessments and the development of contigency plans.
? Partner with the Quality unit to provide quality oversight and ensure all clinical trial materials are manufactured, tested, stored, and shipped in full accordance and compliance with cGMP and country specific regulations.
Educational Requirements: Masters degree (or equivalent work experience) in operations management or a scietific field


Experience Requirements:
? Minimum of 5 years of pharmaceutical development experience with at least 3 years of clinical trial material management experience.
? Experience managing inventory/supplies or complex supply chains.
? In-depth knowledge of clinical research, clinical trial manufacturing, packaging and/or distribution, and interactive response systems (IVR).
? Ability to use and apply multiple computer applications, especially Excel and Microsoft Project.
? Demonstrated project management skills.
? Experience working and communicating with third party contract organizations.
? Knowledge of GMPs/GCPs and other regulations related to CT Materials
? Ability to build collaborative relationships between internal functional groups with competing priorities
? Effective written and verbal communication skills in multi-cultural settings.
? Ability to work in an independent, flexible environment and proactively identify problems and work to-ward a solution.


Additional Preferences:
? 2 years experience in a supply planning or clinical role.
? Experience managing clinical trial materials, complex supply chains, and/or cross-functional projects.
? Degree, certification, or equivalent experience in project management or supply chain management.
? High initiative, learning agility and a flexible, positive attitude.
? Strong quantitative skills and expertise.
? High degree of accuracy and attentive to details.
? Demonstrated leadership and broad expertise within the clinical trial material services organization.


License/Certificate Requirements: None

Language Requirements: Must speak fluent English

美国礼来公司（Eli Lilly and Company）是一家全球性的以研发为基础的医药公司，创立于1876年，总部位于美国印地安那州印第安纳波利斯市。2008年礼来全球销售额突破200亿美元，业务遍及全球 143 个国家和地区，雇佣员工四万多人。

礼来于1918年来到中国，将其第一个海外代表处设在上海。在1993年重新回到中国。已成为业界增长速度最快的制药公司之一。至今，我们在苏州拥有一家独资企业：礼来苏州制药有限公司，30多家办事处，员工已超过1400人。 礼来全球研发中国总部也于2008年10月15日在上海张江高科技园区正式成立。

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