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拜耳医药保健公司招聘信息(二)（09-06-19）

发布日期：2009-6-19

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）

1、osition:    Submissions    Specialist
Responsibilities

·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    Associate
Responsibilities
·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。

联系方式：

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@bayerhealthcare.com    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