Senior Medical Writer招聘_昆泰企业管理（上海）有限公司最新招聘信息-猎才医药网

职位描述

职位描述： PURPOSETake a leading role in preparing or contributing to the production of most types of clinical documents, method validation and study data reports, site manuals, or posters for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices. Acts as mentor for less experienced Medical Writers and assists in their training and development. Participates in project teams.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 and/or technical 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 and/or technical writing processes at full-service bid defence meetings by telephone or in person. May input into and deliver presentations on medical/technical writing to other Quintiles groups.？ May act as Project Manager for a small stand-alone medical and/or technical writing project (e.g. protocol or CSR). May coordinate medical and/or technical 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 and/or technical writing/regulatory knowledge, developments and advances in area of drug development/medical and/or technical writing.？ May propose revisions to SOPs or suggest process improvements for consideration. Complies with Company SOPs and participates in the implementation of new SOPs.REQUIRED KNOWLEDGE, SKILLS AND ABILITIES？ 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 or method validation and study reports, protocols, and similar documents for internal and external clients.？ 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 or pharmaceutical work and/or interpretation of their results.？ Understanding of the time needed to perform routine medical and/or technical writing tasks in order to agree on 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 andauthority.？ Ability to identify deficiencies, errors, and inconsistencies in a protocol or report.？ Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output as related to acceptance criteria according to SOPs.？ Developing skills in providing effective and sensitive written and verbal feedback to junior staff, and to customers when appropriate.？ Confident and effective communication and negotiation skills with customers and project managers.？ Developing skills in chairing small meetings.？ Ability to work on several projects at once while balancing multiple and overlapping timelines.？ Ability to assess and prioritize workload.？ Demonstrated abilities in collaboration with others and independent thought.？ Knowledge of regulations relevant to medical/technical writing, such as Good Laboratory Practices (GLP) and other relevant regulatory agencies (e.g., OECD, MHLW).？ Careful attention to detail and accuracy.？ Must be computer literate.？ Ability to establish and maintain effective working relationships with coworkers, managers and clients. 职能类别：临床数据分析员

公司信息

QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you.

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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