百宝箱 2006-7-10 10:34 AM
辉瑞制药有限公司
registration officer/注册专员
辉瑞制药有限公司(pfizer pharmaceuticals limited)
工作性质： 全职 工作地点： 北京
招聘人数： 1人 薪水： 面议
工作经验： 1年 学历： 本科及以上
职位描述及要求：
there’s one new position opening for a registration officer in medical department, based in beijing, reporting to senior registration manager, please refer to the job description as followed:
公司医学部现招聘注册专员一名，工作地点在北京，向高级注册经理汇报，职位的具体信息如下：
reporting to: senior registration manager
working location: beijing
main job responsibilities主要工作职责：
assist senior registration manager for the applications for new drug products, variations of marketed products and license renewals within the set timeframe and conducting in compliance with local regulatory agency requirements as well as relevant pfizer sop.
协助注册经理进行新产品注册、已上市产品的変更及换证申请工作，确保每个项目运作符合我国相关药品管理办法及辉瑞公司的标准操作程序, 在规定的时间内及时地完成。
in the relevant therapeutic area, provide relevant regulatory supports to the medical groups and to other company ipersonnel.
在相关的治疗领域，为医学部和公司的其他部门提供及时有效的注册事务支持。
assist for the establishment of good working relationship with regulatory agencies and kols as well as hq supporting teams to ensure effective product registrations.
协助建立和相关政府部门，重要专家良好的工作关系；与总部支持团队保持密切的沟通，以确保注册工作顺利进行。
assist for the establishment of good working procedure and regulatory system to implement internal sops and follow external regulations.
协助建立注册团队的工作系统和程序以确保贯彻执行注册法规和公司标准工作程序。
job qualifications 职位要求：
registration project management skill, effective problem solving, organizing and planning capabilities.
一定的注册项目管理能力,有效解决问题, 组织计划能力
essential knowledge on international and chinese regulations as well as technical guidance.
对国际和中国的药政管理指南和法规有一定的工作知识
good communication and team cooperation skill.
较强的沟通能力,团队合作精神
bachelor degree or above in chemicals/pharmaceuticals or related science with a pharmaceutical major.
制药、化学及相关学科，本科或以上学历
2~3 years experience in drug product registrations working at a high level of competency.
2-3年的药品注册工作经验
good english skills both in written and oral.
良好的英文书面及口头表达能力