长沙招聘

Role Description
POSITION DESCRIPTION

Medical Writer Clinical Programming and Writing Group

POSITION SUMMARY 职位概要

Medical Writers in the Clinical Programming and Writing (CPW) Group of China R&D Center (CRDC) collaborate with Point of Contact medical writers (PoC), and members of the clinical study team in Pfizer Development Sites overseas to interpret study results and prepare Clinical Study Reports (CSRs) and related documents. The scope of the work includes global and regional studies across all phases of human development. The writers work closely with biostatisticians and clinicians to ensure the study analysis results and statistical interpretations are accurately and clearly reflected in the CSR.

POSITION DETAILS

Reports to:Supervisor of Medical Writing, CRDC
Department:CPW, CRDC
Location:Shanghai

KEY RESPONSIBILITIES

*Preparation, review and finalization of CSRs or related documents
*Collaboration with biostatisticians and clinical colleagues to interpret study results and ensure timely and accurate integration of data presented in the statistical tables and listings and other information sources into the CSR
*Active participation on clinical study teams in the development of clinical study documents
*Ensure that all medical writing deliverables are prepared according to International Conference on Harmonisation (ICH) and other relevant regulatory guidelines
*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
*Ensure that appropriate quality control (QC) checks are performed on CSRs, other regulatory documents and other medical writing deliverables, as required
*Provide thorough and critical review or peer QC support, of documents prepared by others, as needed
*Ensure own work processes are constantly improved to reflect lessons learned from previous experiences
*May participate in CRDC initiatives to increase efficiency and productivity

ORGANISATIONAL RELATIONSHIPS
Internally to Pfizer the Medical Writers have strong working relationships with:
*PoC medical writers at the commissioning site
*Clinicians
*Biostatisticians
*Programmers and PoC Programmers
*Data managers
*Clinical study managers
*Clinical project managers
*Document Specialists
*Quality assurance auditors

ESSENTIAL CHARACTERISTICS 基本要求

Education学历要求
*At least bachelor degree or equivalent in medical related or life sciences.
医学或生命科学大学本科及以上

Experience
*Knowledge/experience of preparing ICH E3 compliant study reports or medical regulatory documents as a medical writer within or for the pharmaceutical / healthcare / regulatory industry

Technical Competencies技术要求

*Excellent verbal and written English language skills
*Demonstrable ability to communicate clinical data succinctly, clearly and accurately in writing, in English
能够用书面简明，清晰，正确地进行临床数据方面的沟通
*Knowledge of ICH guidelines and regulatory requirements and demonstrable ability to interpret and apply these guidelines in a report writing setting
熟悉ICH 指导方针和新药注册申报法规要求
*Basic knowledge of using Windows OS, MS-Word, MS-Excel, E-Mail (MS-Outlook)
*Basic experience of working in electronic document management systems.

Behavioural Competencies行为要求
*Demonstrable excellent interpersonal and team-working skills exhibiting active listening skills, influencing skills and professional behaviors
*A balanced approach to problems, using flexibility and persistence as appropriate
*Assertive with good influencing skills
*Ability to deliver within agreed timelines and monitor / communicate progress against agreed milestones
根据事先制定的时限，能够提交完成的工作并监察进度
*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 multi-cultural context.
具备在多元文化下有效地工作的能力
*Demonstrated ability to work effectively under pressure
*Attentive to detail

DESIRABLE CHARACTERISTICS 希望具有的特征
Education学历要求
*Post-graduate degree (Masters) or education from universities overseas.
研究生或毕业于海外大学

Technical Competencies技术能力
*Ability to present with similar ease to both scientific and non-scientific audiences.
*Expertise of interacting with cross functional study teams
*Experience of writing Phase 1 to 4 clinical study reports as a medical writer in the pharmaceutical/healthcare industry for at least 2 years.

Behavioural Competencies行为能力
*Demonstrable communication skills in a variety of media settings (e.g. teleconference).
具备远程电话会议沟通能力

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。