*Sr Medical Writer(China-Beijing)(职位编号：1215570)
昆泰医药发展（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2012-11-13
- 工作地点：北京-西城区
- 招聘人数：若干
- 工作经验：三年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：临床研究员
职位描述
Description
The world's leading pharmaceutical services organization is powering the next generation of healthcare. If you want to make a difference in global healthcare, Quintiles is the place for you. You'll be connected with an organization that is changing the way drugs are developed, profiled and marketed. More than 19,000 people throughout the world have already chosen to join Quintiles.
Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one. This is an outstanding opportunity to join Quintiles and become an integral part of our team.
We are looking for suitable individuals to fill the position of :
Sr Medical Writer
Responsibilities
• Acts as Lead Medical Writer on most types of writing project, with limited guidance from senior staff. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer's requirements. Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance. Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Takes responsibility for planning and organizing workload for assigned projects and tasks. Offers proactive solutions and advice to customers as appropriate to experience.
• Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognised as appropriate. May review ballpark budgets and routine costings, with management support as needed.
• May review documents or parts of documents prepared by other Medical Writers and provide appropriate feedback. Gives guidance to less experienced Medical Writers and assists in their training and development.
• May present on standard Medical Writing processes at full-service bid defence meetings by telephone or in person. May input into and deliver presentations on Medical Writing to other Quintiles groups.
• May act as Project Manager for a small stand-alone Medical Writing project (e.g. protocol or CSR). May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking.
• Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing.
• May propose revisions to SOPs or suggest process improvements for consideration. Complies with Company SOPs and participates in the implementation of new SOPs.
Qualifications
• Bachelor's degree in a life science-related discipline, with at least 3.5 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including lead writer roles in preparing clinical study protocols and reports; or equivalent combination of education, training and experience
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
• In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents.
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
• Demonstrated ability and experience to work independently on most writing projects, with limited senior guidance.
• Good understanding of common statistical methods used in clinical trials and interpretation of their results.
• Understanding of the time needed to perform routine Medical Writing tasks, agree appropriate timelines, and provide accurate resource estimates and costings. Knowledge and understanding of necessary budget assumptions.
• Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and authority.
• Ability to identify deficiencies, errors, and inconsistencies in a protocol.
• Ability to effectively review a statistical analysis plan.
• Ability to identify deficiencies, errors, and inconsistencies in statistical output.
• Knowledge of regulations relevant to medical writing.
The world's leading pharmaceutical services organization is powering the next generation of healthcare. If you want to make a difference in global healthcare, Quintiles is the place for you. You'll be connected with an organization that is changing the way drugs are developed, profiled and marketed. More than 19,000 people throughout the world have already chosen to join Quintiles.
Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one. This is an outstanding opportunity to join Quintiles and become an integral part of our team.
We are looking for suitable individuals to fill the position of :
Sr Medical Writer
Responsibilities
• Acts as Lead Medical Writer on most types of writing project, with limited guidance from senior staff. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer's requirements. Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance. Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Takes responsibility for planning and organizing workload for assigned projects and tasks. Offers proactive solutions and advice to customers as appropriate to experience.
• Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognised as appropriate. May review ballpark budgets and routine costings, with management support as needed.
• May review documents or parts of documents prepared by other Medical Writers and provide appropriate feedback. Gives guidance to less experienced Medical Writers and assists in their training and development.
• May present on standard Medical Writing processes at full-service bid defence meetings by telephone or in person. May input into and deliver presentations on Medical Writing to other Quintiles groups.
• May act as Project Manager for a small stand-alone Medical Writing project (e.g. protocol or CSR). May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking.
• Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing.
• May propose revisions to SOPs or suggest process improvements for consideration. Complies with Company SOPs and participates in the implementation of new SOPs.
Qualifications
• Bachelor's degree in a life science-related discipline, with at least 3.5 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including lead writer roles in preparing clinical study protocols and reports; or equivalent combination of education, training and experience
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
• In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents.
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
• Demonstrated ability and experience to work independently on most writing projects, with limited senior guidance.
• Good understanding of common statistical methods used in clinical trials and interpretation of their results.
• Understanding of the time needed to perform routine Medical Writing tasks, agree appropriate timelines, and provide accurate resource estimates and costings. Knowledge and understanding of necessary budget assumptions.
• Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and authority.
• Ability to identify deficiencies, errors, and inconsistencies in a protocol.
• Ability to effectively review a statistical analysis plan.
• Ability to identify deficiencies, errors, and inconsistencies in statistical output.
• Knowledge of regulations relevant to medical writing.
公司介绍
ABOUT THE COMPANY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY