长沙招聘

工作职责:

Role Summary:

The Medical COE Associate provides primary operational support to various programs within Global Medical Operations, Governance and Community (GMOGC) group which including but not limited to Global Medical Grants (GMG), Clinical Research and Collaboration (CRC), Compound Transfer Program (CTP), Clinical Data Request (CTD), and Publications Programs.

The major responsibilities including but not limited to:  Maintaining systems, Share Point sites and databases used for program management; Receive, generate and distribute program related documents & report according corresponding Pfizer SOPs and guidelines; Process  eligibility check, finance transactions and drug distribution as requested.

The Medical COE Associate will work closely with program managers with necessary communication and coordination to ensure efficient program process and compliance.

  Role Responsibilities:

The support areas of Global Medical Grants requests include but not limited to:

Performs due diligence on grant requestor, ensure the requesting organization and/or the grant requester is not listed on any national, international or internal exclusions lists. Verify accreditation at the organization level or at the activity level when applicable and review grant request for accuracy and completeness.

Coordinate request review process including setting approval workflow and preparing necessary review documents. Ensure Reviewer/Approver reference table is up to date.

Partner with medical reviewers and approvers to allocate payment and set milestones. Select the appropriate contract template for signature and execution.

Manage financial transactional details as well as drug supply requests based upon executed contract and milestone payments; Work with Program Managers / CRC Liaisons and Pharmaceutical Sciences Supply Chain Coordinators to ensure clinical supply forecasts are up-to-date and supplies are available as required.

Manage regular program oversight activities for enrollment, IRB approval/renewals and progress. Forward program update documentation to the appropriate reviewer and release the milestone payment if applicable.

Assists CRC Liaisons or Program Managers with status report, queries and other logistic support as required.

Partner with global team and contribute to process and business technology improvement projects within areas of responsibility, as requested.

The support areas of Publications include but not limited to:

Support publication activities by completing watch list checks and related forms, in relation to determining if external manu"script" authors are included on any debarment watch lists, as per publication SOP

Responsible for providing access to DataVision (DV) to internal and external stakeholders by ensuring that appropriate training has been completed for the requested role

In partnership with the Publication Specialists and Publication Manager of Operations, support the management of monthly invoice processing from publication vendors (~200 invoices/month), including reconciliation of records in DataVision (DV) and confirmation of receipt of deliverables prior to invoice payments. 

任职资格:

QUALIFICATIONS

Bachelor’s degree (BA, BS) required with preference for a focus in science, healthcare or related field.

Good written and oral English skills, Japanese fluency highly desired.

Operational experience in clinical trial management, educational grants or healthcare industry (pharmaceuticals, life sciences, and medical).

Knowledge of IT systems/software for database maintenance and document management.

Demonstrated effectiveness working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change and diversity.

Good understanding of multiple disciplines (e.g., Healthcare Compliance Law, Regulatory, Drug Supply, Clinical Study, Medical Affairs, Medical Educational Grant, Publication development, Project and Financial Management) and organizations (e.g., Pfizer Country Offices and Regions)

Experience with various Pfizer processes/systems/functions: MAPP (FCPA), Ariba SAP reporting strongly preferred.

Developed customer service skills and team work spirit.

  

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。