长沙招聘

职位描述：
Primary Responsibilities
? Accurately identify and generate prose narratives for regulatory submissions according to the narrative plan by proactively monitoring the safety database and initiate narrative writing, as needed, to keep within study deadlines
? Ensure narratives conform to regulatory and agreed internal standards
? Ensure documents are generated in accordance with agreed internal processes and standards (eg Pfizer Global Document Style Guide), are submission ready and appropriately stored in an agreed document management system
? Provide thorough QC support of documents prepared by others, as needed
? Actively manage workload and track narrative progress during clinical team reviews and QC
? Prepare documents for internal audit and address any audit findings accurately and in a timely fashion
? Develop and maintain knowledge of all applicable global regulations and guidelines, standard operating procedures and practices
? Understand the functions and roles within the study team and the Safety lines (Worldwide Safety Strategy and Worldwide Regulatory and Safety Operations) and communicate and align with them in the delivery of narratives to meet project-related goals
? Ensure own work processes are constantly improved to reflect lessons learnt from previous experiences
? Assist with special projects, as requested
? May participate in CRDC initiatives to increase efficiency and productivity

Technical Skill Requirements
? Excellent grasp English, both written and verbal, able to communicate effectively.
? Extensive clinical knowledge
? Demonstrable ability to communicate clinical data succinctly, clearly and accurately in writing, in English
? Knowledge of International Conference on Harmonisation (ICH) guidelines and regulatory requirements and demonstrable ability to interpret and apply these guidelines in a report writing setting
? Knowledge of the safety database and other narrative generation tools
? Basic experience of working in electronic document management systems
? Basic knowledge of using Windows OS, MS-Word, MS-Excel, E-Mail (MS-Outlook)

Qualifications
? At least bachelor degree or equivalent in medical-related or life sciences.
? Knowledge/experience of preparing safety narratives or medical regulatory documents as a medical writer within or for the pharmaceutical / healthcare / regulatory industry
? Clinical experience required
? Ability to manage multiple priorities within timeframe
? Ability to work effectively under pressure
? Must be accurate and have an excellent attention to detail
? A balanced approach to problems, using flexibility and persistence as appropriate
? Ability to deliver within agreed timelines and monitor / communicate progress against agreed milestones
? Demonstrable excellent interpersonal and team-working skills exhibiting active listening skills and professional behavior, assertive
? Ability to work in a matrix organization with people in cross-functional lines and scientific staff from a range of disciplines
? Ability to work effectively in a multicultural context and with colleagues in different country operations

Preferred Additional Experience
? Post-graduate degree (Masters or above) or overseas university education
? Ability to present with similar ease to both scientific and non-scientific audiences
? Expertise in interacting with cross functional study teams
? Experience in writing Phase 1 to 4 clinical study reports as a medical writer in the pharmaceutical/healthcare industry for at least 2 years.
? Demonstrable communication skills in a variety of media settings (e.g. teleconference) 举报 分享

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。