长沙招聘

Clinical Supply Strategy:

· Responsible for leading the development and execution of investigational and commercial material global supply strategies for early and late stage development programs intended for regulatory approvals of new products, new indications, or line extensions of currently approved products.

· Participate as a key member of the Pharmaceutical Sciences Project Team (PSPT) and Co-Development Team (CDT) to proactively recognize and address logistical and regulatory issues associated with the requirements of the clinical development program and project team objectives.

· Participate as a core study team member to provide operational knowledge relating to Investigational Product (IP) and lead strategy discussions to align with protocol and operational needs for each study. Proactively anticipate changes based on operational factors (countries, sites, enrollment), randomization configuration and protocol requirements

· In partnership with the CST, develop clinical supply solutions, including packaging, blinding, and distribution strategies, that meet the needs of clinical studies as well as ensure patient compliance and safety. · Proactively identify risks and develop strategies to mitigate these risks and create contingency plans that minimize the impact of unanticipated events.

· Manage clinical trial drug supply budget and communicate forecasts and changes effectively and in a timely fashion to study teams and GCS partner lines.

· Utilize Digital Supply Chain tools and understanding of clinical development plans to project drug supply demand.

· Maintain project information in GCS project tracking systems and in PharmSci project management systems. · Ensure site and patient focus, along with quality compliance, throughout PharmSci and GCS processes. Contribute to the investigation and implementation of corrective and preventative actions for Significant Quality Events (SQEs) and Good Manufacturing Practices (GMP) Incidents.

· Receive and assist in assessment of all clinical complaints.

· Act as a point of contact for clinical supply required input during audits and regulatory inspections. Participate in inspection readiness activities.

· Participate on Limited Duration Teams and Continuous Improvement projects. Matrix Team Leadership: · As the matrix team lead of the CST manage a network of internal and external partners to ensure GCS meets the customer expectations and supports the key Pfizer clinical study milestones and patient supply needs.

· Establish and maintain behavioral norms and performance expectations for the CST, ensure open sharing of issues, engage team in solving problems, establish collective accountability for supply chain deliverables, ensure that team members are clear on their individual roles and responsibilities and regularly assess team performance.

· Assess CST member strengths and through strong leadership motivate others to perform functional tasks to meet team goals.

· Demonstrate teamwork by effectively interfacing and communicating with customers, GCS partners (Pharmaceutical Sciences Team Leads (PSTLs), Clinical Supply Operations (CSO), Quality Operations, Import/Export, Global Chemistry, Manufacturing and Controls (GCMC), Clinical Research Pharmacists (CRPs) and other colleagues. QUALIFICATIONS Basic Qualifications: B.S. degree (or equivalent) is required. Advanced training in supply chain management, a scientific discipline, project management, or business administration is desirable. Business English and Japanese skills are desirable.

Preferred Qualifications:

· Drug development, scientific research, or clinical study design including telerandomization, , pharmaceutical manufacturing/packaging/labeling/distribution/Import export..

· Management of multi-disciplinary teams that includes measuring work, negotiation, conflict management, process improvement, project management.

· Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders

· Experience managing change in a dynamic, complex environment

· Experience with budgeting and forecasting

ORGANIZATIONAL RELATIONSHIPS

· Report to a DBO Asia Team Lead

· Liaise with key internal customer contacts (WRD, PIH, PEH) to gather clinical development plans, and review supply strategies.

· Interface with Global Product Development (GPD) and/or CROs to lead supply strategy and execution associated with study management activities.

· Build and maintain strong partnerships with Supply Chain workstreams and partner lines as the leader of the CST. · Interface with GPD Clinical Program Manager (CPM) to link program level supply strategy with contracted development efforts.

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。