长沙招聘

工作职责:

Works closely with clinical study team to establish strategy, timelines, and project management for the reporting of clinical study data

Collaborate with clinical study team members to prepare clinical study/trial protocols

Collaborates with clinical study team members to interpret study results and prepare Clinical Study Reports (CSRs) and related documents

Works closely with biostatisticians and clinicians to ensure study analysis results and statistical interpretations are accurately and clearly reflected in the CSR

Manages all aspects of CSR production and ensures timely project delivery

Ensures final CSRs conform to ICH-E3 guidelines and the Pfizer Global Document Style Guide

Ensures ‘public disclosure’ related components of CSRs are finalized to enable timely release of results into the public domain

Write or help write clinical and regulatory documents to enable global and China regulatory submissions (IND, CTA, NDA/BLA/MAA, briefing packages) in CTD format

Write other clinical and regulatory documents including but not limited to patient safety narratives, basic results/public disclosure synopses, development-China-specific documents such as SARs, progress reports, subgroup analysis CSRs, bridging reports, China study protocols and CSRs, China submission documents.

任职资格:

Primary Responsibilities

? Prepares, edits, and finalizes CSRs or related documents

? Collaborates with biostatisticians and clinical colleagues to interpret study results

? Works with groups outside CPW, e.g. Regulatory, CSR Coordinator, Clinical Trial Disclosure Group, QA

? Participates actively in clinical study teams in the development of clinical study documents

? Understands the functions and roles within the study team and aligns with them in delivery of CSRs to meet project-related goals and to meet external results disclosure obligations

? Ensures CSRs accurately reflect the data presented in the statistical tables and listings and other information sources

? When required, prepares, edits and finalizes the protocol and any amendments in collaboration with team members (e.g., Clinician, Clinical Pharmacologist, Safety Risk Lead, Statistician).

? Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines

? Ensures documents are generated in accordance with agreed internal processes and standards (e.g. Pfizer Global Document Style Guide), are submission ready, and appropriately stored in agreed document management system

? Ensures that appropriate quality control (QC) checks are performed on CSRs and other medical writing deliverables

? Provides thorough and critical review or peer QC support of documents prepared by others, as needed

? Ensures ‘public disclosure’ related components of CSRs are finalized to enable timely release of results into the public domain

? Supports corporate audit and regulatory inspections through attendance of related inspection meetings and has thorough documentation procedures integrated into daily work practices so as to facilitate such inspections

? Develops and maintains knowledge of all applicable global regulations and guidelines, SOPs, and practices

? Ensures own work processes are constantly improved to reflect lessons learned from previous experiences

? Work with other group members to enable improved quality and consistent format of CSRs

? Participates in CRDC and CII initiatives to increase efficiency and productivity; may lead selected teams in these efforts

? Implement recommendations for improvements to the CSR process

? Align with department management to set strategy for meeting department goals

? When needed, write or help write other clinical and regulatory documents not mentioned above

? Technical Skill Requirements

? Excellent verbal and written English language skills

? Demonstrates understanding of clinical data and has ability to communicate it succinctly, clearly, and accurately

? Knowledge of ICH guidelines and regulatory requirements and demonstrable ability to interpret and apply these guidelines in a report writing setting

? Ability to guide others in application of internal or regulatory guidelines

? Demonstrated excellent project management skills

? Basic knowledge of using Windows OS, MS-Word, MS-Excel, and MS-Outlook

? Basic experience of working in electronic document management systems

? Qualifications

? At least BS or equivalent in the medical or life sciences field

? Good understanding of pharmaceutical R&D processes

? Knowledge of global regulations and guidelines (FDA, ICH) and regulations of China and other Asian countries that pertain to the drug development process and production of CSRs

? Experience in interacting with cross functional study team members

? Experience in preparation of ICH E3-compliant CSRs within the pharmaceutical industry

? Demonstrates good communication skills in a variety of media settings (e.g. teleconference).

? Ability to present with ease to both scientific and non-scientific audiences

? Attentive to details

? Demonstrates strong interpersonal skills and has the ability to work in a multi-cultural environment

? Ability to communicate professionally with cross-functional lines, scientific staff from a range of disciplines, and all levels of management

? A balanced approach to problems, using flexibility and persistence as appropriate

? Ability to deliver within agreed timelines and communicate progress against agreed milestones

? Ability to multi-task and work effectively under pressure; demonstrate excellent project management skills

? Ability to work independently with minimal supervision

Demonstrated ability to focus on the customer, while setting realistic expectations for them

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。