北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京医药技术研发人员招聘

Associate Medical Affairs Manager

中美天津史克制药有限公司

  • 公司规模:500-1000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:2013-01-09
  • 工作地点:上海-静安区
  • 招聘人数:2
  • 工作经验:二年以上
  • 学历要求:硕士
  • 语言要求:英语熟练
  • 职位类别:医药技术研发人员  

职位描述

职位目标 Job Purpose:(请简述设置该职位的原因及必须达成的目标/why job exists and what is expected to achieve)
? 确保高质量医学监管Ensure medical governance implementation throughout the business
? 丰富医学背景,强有力的市场支持Comprehensive medical support for marketing initiatives
? 保证公司药品临床研究的顺利完成,为其他部门提供有关产品的医学支持
Ensure TSK&F sponsored or supported clinical trial to be finished smoothly and provide medical support to other departments
主要工作职责 Key Responsibilities: (概括关键职责、每项职责所要达成的结果/primary deliverables of roles)
1. 履行公司业务战略,按照设定的目标取得卓越的成绩,并积极支持和参与OTC医学团队发展。In line with the business interests of TSK&F, achieve the target excellent and proactive support & participate OTC medical team building
2. 参与新药研发相关事宜,提供有价值的医学信息和评估。Involve in new drug development and provide valuable medical information and evaluation.
3. 为注册性/上市后临床试验设计/审核研究方案。Design/review protocol for registration clinical trial/post marketing study
4. 全面掌握疾病和相关品牌产品的知识和数据,为当地品牌产品发展产品宣称。Comprehensive understand the knowledge and data of responsible therapeutic area and brands and develop claims for the products in responsible brand
5. 确保负责品牌的所有推广活动和推广资料经过及时审核,保证质量和符合伦理要求。Ensure all TSK&F promotional activities/materials to be reviewed timely, in high quality and to meet ethical requirement
6. 对负责品牌产品的上市后商业推广提供医学支持。Provide medical supports to promotional activities of post marketing products in responsible brand
7. 协助上级主管发展医学事务相关SOP并确保贯彻执行。Support the supervisor to develop Medical Affairs SOPs and ensure the full compliance
8. 协助上级主管一起审核所负责品牌的人体试验,并且确保获得医学批准。 Support the supervisor to review the protocols for human studies and ensure to get medical governance approval prior to initiation.
9. 高质量维护和发展负责品牌领域和公司涉及的治疗领域的KOL团队。Maintain and develop a KOLs team with high quality in responsible brands and the therapeutic areas of TSK&F interests
10. 完成上级主管交给的任务。Accomplish any other tasks assigned by the supervisor.
责任范围 Accountability Scope :(与该职位所要达到主要业绩相关的因素;直接报告、非直接报告的下属的人数;预算控制范围和责任,以及经常性的跨部门/职能的工作责任/ factors related to the result of this role: direct/indirect reports; budget; job territory; impact )

? 人员管理 Management of people:
– 直接下属 Direct reports: 0
– 间接下属Indirect reports: 0
? 预算控制 Budgetary Control: 协助上级主管负责品牌医学事务预算 Budget of each medical affairs.
? 工作领域 Job Territory (请简述该职位负责的部门、职能、 地域等/Department, function or region):
医学事务部,临床研究与医学事务,中国
Medical Affairs, Clinical Operation and Medical Affairs Dept, China
? 该职位的决策范围和影响程度Impact on strategy, policy or business:
为上级主管提供负责品牌的正确,科学的医学支持,以便其作出最适合的新产品临床研究策略,确保公司市场推广符合公司和中国的相关法律法规。
Provide right and scientific medical support to the supervisor to let the supervisor make the most appropriate new product clinical study strategy, ensure business strategy follow GSK and national policy & legal issue.
任职条件Qualifications: (该职位任职者所需具备的成功要素/ Key success factors the job holder should have)

? 文化程度Education (学历/专业Diploma, Degree and Major):
大学本科或以上学历,医学专业
Bachelor degree of medical/clinical science or above.
? 任职经验Working Experience:
3年以上制药行业药品医学相关工作经验,外资药业工作经验为佳。
More than 3 years medical related experience in Pharmaceutical, foreign pharmaceutical company is preferred.
? 专业知识/技能Professional Knowledge/Skill :
1. 医学专业知识
Medical professional experience and knowledge
2. 市场和销售知识
Marketing and Sales knowledge
3. 熟悉产品知识及相关疾病的知识
Familiar with knowledge of TSKF product and related disease.
4. 计划和项目管理
Project planning and management
5. 国家药政法规
State Pharmaceutical Administration Regulation
6. 药品临床研究规范
GCP(Good?Clinical Practice), SOP(Standard Operating Procedure)

? 计算机及外语水平Computer & Language Skill:
1. 熟练的计算机操作能力
Skilled computer capacity
2. 流利的英语听说读写能力;能够熟练使用专业英语进行语言或文字的技术交流以及论文书写
Fluent in written & spoken English, skillfully use professional language in English for communication and thesis writing.
? 能力要求Competency:
良好的计划、组织和协调沟通能力
Master good ability on planning, organizing, coordinating and communication
? 领导力 Leadership (请从GSK八项领导要素中选择与本岗位直接相关的3-5个/Please identify 3-5 from the 8 GSK Leadership Essentials which directly support the responsibilities)

目标一致,协同共进
Alignment with GSK Interests

信守承诺,争做贡献
Everyone Committed, Everyone Contributing

? 复杂性Complexity:(写出工作中环境的不确定因素,以及哪些需要分析资料或复杂情况后才能作出的决定和/解决的问题/Please describe the uncertainties and complexities need to be handled by this position)

? 工作中的不确定因素 Uncertainty:
某些产品相关的医学评估,以及临床研究立项和申请、资料准备过程中,均需要先搜集全面的信息后进行分析。
Collect and analyze product’s comprehensive information when doing medical evaluation, planning & applying clinical trial and preparing study documents.
? 工作中需要复杂分析的情况 Complexity for Analysis:
1. 产品的医学评估要兼顾相关领域的最新进展情况,如出现了新的理论和竞争产品,需要重新分析。
Medical evaluation of product need consideration of the newest update in related therapeutic area, such as re-evaluation needed when new theory and competitors occur.

2. 制定临床研究方案,确保临床方案不仅符合GSK的要求,同时满足中国药政管理的要求;
Not only need to meet the GSK’s requirement, but also need to meet SFDA’s requirement of when preparing protocol for clinical trial.

? 沟通复杂性 Complexity for Communication: (指该职位在工作中经常性的且最具挑战性的沟通,包括与组织内部及外部的沟通/ The most frequent and challenging communication. Internal & external)
1) 内部沟通 Internal:
? 协助或/和参与负责品牌相关项目的及时沟通,对项目提供专业医学意见,并定期更进;
Support or/and participate communication for responsible brands’ projects, provide medical comment for the projects and conduct routine follow up.
? 及时与所负责品牌的相关部门沟通,了解其需求为市场部和销售部及时提供医学专业支持,准备上市后产品临床研究文件;支持培训部完成产品培训资料的更新。
Communicate timely with related Dept for responsible brands, understanding their needs, provide medical support to marketing and sales, prepare post approval clinical study documentation, support training Dept for updating of training materials.
2) 外部沟通 External:
? 密切联系相关领域的专家,掌握和确认最新的疾病、治疗领域的专业信息,确保负责品牌发布的相关信息正确并且符合策略。同时参与和临床研究牵头人沟通,确保临床研究的方案科学性和可行性。
Closely communicate with KOLs and get updated information in related therapeutic area, to ensure that TSK&F delivered message correctly and is consistent with the strategy. Whilst participate in communicating with clinical research investigators, ensure the study protocol is scientific and practical.

公司介绍

中美天津史克制药有限公司是全球***的制药企业之一的葛兰素史克(GSK)与国内大型制药企业天津中新药业股份有限公司和天津太平(集团)有限公司共同投资设立的制药企业。

作为***在华设立的外商合资制药企业之一,中美史克早在1987年便在中国生根。20年来,中美史克一直秉承着大爱铭心的理念,用优质的产品和爱心回报社会。2008年,中美史克家族除了消费者耳熟能详的四大OTC品牌新康泰克、芬必得、百多邦、史克肠虫清外,还成功上市了全球牙医首选推荐的抗牙敏感牙膏舒适达; 新康泰克和芬必得两大品牌家族又添新成员,2008年,新康泰克红色重感装成功上市;2009年,芬必得酚咖片新头痛装的成功上市,中美史克将更好地呵护人们的健康生活。

中美史克注重以人为本,有着激动人心的“3T”企业文化。2007年开始推行的“3T”文化经过一年来的渗透,在2008年更加深入人心。
相互信任(Trust)、开放透明(Transparent)、积极主动 (Take initiative)的“3T企业文化”如今已成为史克员工日常的工作方式,引领着员工与企业共同成长。

联系方式

  • Email:jenny.y.zhang@gsk.com
  • 公司地址:天津市