拜耳医药保健公司（北京）

职位：2009招聘
发布时间：2009-04-28
工作地点：北京
信息来源：北京大学医学部
职位类型：全职
职位描述
拜耳医药保健公司招聘信息(09-04-28)

发布日期：2009-4-28

拜耳医药保健公司招聘信息 拜耳医药保健和中国的渊源可以追朔到二十世纪初期，拜耳早在1936年就开始在上海生产销售阿司匹林。今天的拜耳医药保健在中国已经拥有3000多名雇员，4个业务 群：拜耳先灵医药、保健消费品、糖尿病保健和动物保健。拜耳医药保健作为拜耳集团的子集团是世界领先的医药保健、医疗产品制造企业。拜耳医药保健在全球是由动物保健、保健消费品、糖尿病保健和拜耳先灵医药共4个部门组成。2007年拜耳医药保健收购先灵，成立拜耳先灵医药部，拜耳先灵医药部包括有四个业务部门：普药业务，影像诊断业务、抗肿瘤/特殊治疗业务、女性健康业务。2006年拜耳医药保健全球销售额达117亿欧元。拜耳医药保健的目标是研究开发、生产和销售用于预防、诊断和治疗疾病的原研产品，拜耳医药保健致力于提高人类及动物的健康水平。目前由于新业务的发展，我们需要招聘以下职位： 1.Submissions Specialist资料递交专员(见下1) 2.Compliance Associate 合规助理（见下2） 请谅解：简历投递方式仅为电子邮件投递，不接受其它投递方式。 Email：lei.gong@ 人力资源部 公司地址：北京朝阳区东三环中路7号北京财富中心写字楼1、osition: Submissions SpecialistResponsibilities·The Incumbent executes all operational activities associated with compilation, publishing and distribution of submission dossiers for new and lifecycle management projects submitted to local and/or global Health Authorities under the direct supervision of a Global Submissions Leader. ·As part of the submission compilation process, coordinates the technical review / technical improvement and verification of the eCTD compliance of dossier-relevant R&D documents/reports consistent with appropriate standards. ·This is achieved by enhancing the technical quality of submission relevant documents/reports and/or collaborating with authors. ·The individual is trained on relevant Health Authority requirements regarding (electronic) submissions and processes. ·Responsible for applying all global regulatory guidance and regulations associated with the technical assembly and publication of submissions (paper, electronic and/or non ICH formats) with oversight from a GSL and/or GSM&A management. ·Ensures achievement of submission milestone dates for assigned publishing support activities. ·Identifies and documents issues that risk the submission timelines and escalates the issues to the GSL and/or GSM&A management to recommend appropriate resolution. Qualifications·BS or equivalent (degree preferred) in a life science or computer science.·Relevant experience may be met via a combination of electronic data/document management, project management, computer systems or publishing software support, electronic document publishing and/or regulatory affairs. ·Knowledge of drug development process and relevant SOPs is required along with an understanding of federal regulations, international standards (e.g. ICH), and regulatory guidances as they pertain to the development and filing of e-submissons. The ability to interpret implications of these regulations, apply them to daily operations and to respond appropriately to questions from peers and cross functional professional staff is imperative. ·Must have an excellent working knowledge of word processing, document management, and desktop publishing software packages, including hands-on knowledge of various document types, authoring tools and file formats (such as MS office templates, PDF files, SAS program/transport files, XML program code, etc.). Additionally, previous experience with a document management or electronic publishing tools is needed (such as PDF Fusion, EZsubs, Core Dossier, ISI Toolbox, Docubridge etc.). Must have an excellent working knowledge of databases and data structures (such as Lotus Notes databases, Oracle IMPACT, MS Access, SAS, etc.). ·Strong communication and interpersonal skills are needed to interact with global document authors and their support staff across international Bayer sites and across different functional departments. Multi-cultural sensitivity gained from some direct international experience is highly recommended. ·Exposure to the project management function, tools and techniques as they apply to Regulatory submission projects is highly desirable. Self-motivation, a sense of urgency, attention to detail, sound judgement, and good follow-through are also essential. · 岗位名称：资料递交专员岗位职责：·负责对新产品及已有产品的申报资料的编辑、最终成稿及分发，在全球资料递交负责人的直接监管下负责递交至当地和/或全球卫生主管部门；·作为整个递交过程中的一部分，要协调技术审查/技术改进和确认药品电子申报（eCTD）材料中相关研发文件/报告符合相应的标准；·通过与文件或报告的撰写者合作，或者通过提高所递交的文件或报告的技术质量来达到最后取得批准的目标；·参加卫生主管部门要求的有关（电子）提交和申报流程的培训；·负责根据所有的全球规定和规章，包括根据有关于递交资料（纸质版，电子版和/或非ICH版本）的最终成稿规则来执行，并接受GSL的监督和/或GSM&A的管理；·确保完成材料递交后的资料备份工作；·及时发现并记录影响递交时限的问题，并向GSL和/或GSM&A管理层汇报以便他们采取相应的解决措施。岗位要求：·生命科学或计算机科学学士学位（首选）或同等学历。·相关实习经验包括以下领域的工作：电子数据/文件管理，项目管理，计算机系统或出版软件的支持，电子文件出版和/或注册事务；·了解药品开发程序及相关的标准操作规程（SOP）,了解药品开发和电子提交的归档相关的地方规章及国际标准（如ICH），具有对这些规定的口译能力，将其用于日常业务，并对用户的问题做出适当反应，能够跨部门开展专业工作·熟练操作文字处理，文件管理，和桌面出版软件，包括各种文件类型，书写工具和文件格式的操作（如MS Office范本，PDF文件，SAS程序/转换文件，XML的程序代码，等等）。具备使用文件管理或电子出版工具的经验（如PDF Fusion,EZsubs，Core Dossier,ISI Toolbox,Docubridge等），熟悉数据库和数据结构的相关知识（如Lotus Notes数据库，Oracle IMPACT,MS Access,SAS等）；·具备优秀的沟通能力和人际关系技巧，因需要通过国际拜耳网站与全球的文件作者或他们的合作伙伴联系，也要与不同的职能部门联络。尤其应具备对多元文化的敏感性；·曾承担过项目管理职责，使用过相关工具和技术的人员优先，要能够自我激励，具备紧迫感，注重细节，有良好的判断力并善始善终。2、Position Title: Compliance AssociateResponsibilities·Works autonomously in a team in agreement with the global Regulatory Compliance functions (e.g. Database Compliance, Database Development, Quality Management SOP & Training, Quality Compliance Office). ·Responsible for accurately capturing RA data into global tracking system to keep the GRA business compliant with requirements of Health Authorities. ·Quality assurance of the data input and consistency in the regulatory tracking data base.·Central creation of data entry masks for subsequent processing at local regulatory affairs functions.Qualifications·Advanced degree in life sciences , scientific education (e.g. medical laborary/certified pharmacy technican [MTA/PTA]) or equivalent.·on-the-job experience, preferable in the pharmaceutical area. ·Good (written and spoken) English language skills, experience in working with databases and the will to train and use new application(s) intensively. ·Good skills in working with Window Office Applications (e.g. Word, Excel).Flexible time management depending on current work-load. ·Polite and supportive relation to the customer. ·Highly accurate and reliable way of working, ability to work in a team combined with independent execution of assigned tasks, proactive, ability to work under pressure, coordination skills, discretion.·Professionalism is essential, as the job holder has to work directly with different hierarchical levels within BSP. ·The ability to establish relationships between individual departments is an essential requirement.·The job holder must be able to absorb large amounts of information efficiently, give sound judgments and remain calm in order to manage difficult problems effectively.岗位名称：合规助理岗位职责·在全球法规的框架（数据库规则，数据库开发，质量管理SOP及培训、质量标准办公室）下在团队中自主开展工作；·负责准确获取注册数据，使之纳入全球跟踪系统，以便GRA商务团队能够遵循卫生主管部门的要求；·保证注册数据库中输入数据的质量及一致性；·为当地注册事宜的后续过程建立数据录入屏蔽。岗位要求：·生命科学、科学教育硕士及以上学位（如医疗实验室/认证药剂学[MTA/PTA])或同等学历；·相关实习工作经验，有制药学领域实习经验者优先；·英语（写作与口语）水平优秀，有数据库实习工作经验，愿意接受培训并使用新的应用软件；·熟练操作Windows办公软件，能够根据目前的工作负荷灵活地管理时间；·礼貌对待客户，并支持形成良好的顾客关系；·工作方式高度精确、可靠，有较强的团队合作能力且能独立完成分配的任务，积极主动，能够在压力下工作，具备良好的沟通协调能力，能谨慎处理事务；·必须具备专业精神，因为该职位的员工需要与BSP内不同级别的员工一起工作；·必须具备沟通协调部门间关系的能力；·该职位员工必须能够高效吸收大量的信息，提供有力的判断和保持冷静，以有效地处理难题。