Medical Development Manager
上海任仕达人才服务有限公司
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2013-08-23
- 工作地点：北京
- 招聘人数：1
- 学历要求：硕士
- 职位类别：医药技术研发管理人员
职位描述
Position Title: Medical Development Manager
某外资制药公司医学部
有兴趣请发简历到joy.wang@randstad.cn
Department: Clinical Development
Division :Division: Research & Development
Reports to: Director of Asia GCDTherapeutic Area Head(s)
Dotted line report: Local Medical Director
Primary Purposes of Position:
The position is responsible and accountable for the development of the medical aspects of the Clinical Development Plan deployed in China as directed by the relevant Clinical Development Therapeutic Area Head in partnership with the Global project team, and in accordance with the overall TPP as provided by the franchise.
To deliver quality and timely medical input and interpretation on specific product data in fulfilment of the Development business objectives for registration
To work in partnership with regulatory affairs, clinical operations and pharmacovigilance in providing medical support for clinical development, including responses to regulatory agency queries
To ensure that GCPs, Ethics, medical compliance is applied within all clinical development activities. The incumbent is accountable to the CMO
Main Duties to be performed:
? Under the direction of the designated Therapeutic Area Head and in close collaboration with key stakeholders, to medically monitor clinical development programs deployed in China
? To provide medical expertise and lead as required :
- documentation including but not limited to the IB, clinical summaries, response to queries from the regulatory authorities, clinical study synopses and protocols, in line with clinical development plan,
- discussion and conclusion on Clinical Study Reports and to ensure the coherence on the interpretation of the data through the clinical development plan in line with the target product profile
? To monitor & facilitate the conduct of clinical studies, to alert the project team to any safety issues which may have a potential impact on the clinical development of the product or its target market
? To inform the Clinical Development Therapeutic Area Head with up to date project status reports
? To be co-responsible with clinical operations of clinical trials and proactively identify potential problems of a clinical nature that might have a deleterious effect on a program’s timely completion and report these to the project team
? To propose upon consultation with clinical operations pragmatic solutions to insure the efficient ethical & quality conduct of clinical trials
? To establish and maintain professional relationships between the company, external medical experts and key opinion leaders and to represent Drug Development at investigators’ meeting or expert panels as required
? To provide tactical support as required on Joint Development Committees and Due Diligences
? To proactively liaise with the Translational Sciences group and Franchises to inform them about the progress of the clinical development program, to help them to evaluate potential business risk
? Generic and Managerial responsibilities :
> Perform any other activity that may reasonably be required from time to time.
> Complete all of the above activities within the framework and in compliance with the R&D SOPs and other documentation in force in the Ipsen Group.
> Develop and maintain state of the art scientific and medical knowledge through strong external professional network
> Be an active member and contributor to Ipsen’s medical community
Specifics of Position:
Significant international travel required
Education:
- Ideal: Post graduate professional qualifications required in addition to Medical qualifications (equivalent in UK of Membership of Royal College of Physician or Fellowship of Royal College of Surgeons)
- Minimum: Medical degree
- Languages: Chine - English
Experience (Proficiency):
- Ideal: At least 5 to 8 years clinical development experience
- Minimum: Substantial experience in pharmaceutical drug development
某外资制药公司医学部
有兴趣请发简历到joy.wang@randstad.cn
Department: Clinical Development
Division :Division: Research & Development
Reports to: Director of Asia GCDTherapeutic Area Head(s)
Dotted line report: Local Medical Director
Primary Purposes of Position:
The position is responsible and accountable for the development of the medical aspects of the Clinical Development Plan deployed in China as directed by the relevant Clinical Development Therapeutic Area Head in partnership with the Global project team, and in accordance with the overall TPP as provided by the franchise.
To deliver quality and timely medical input and interpretation on specific product data in fulfilment of the Development business objectives for registration
To work in partnership with regulatory affairs, clinical operations and pharmacovigilance in providing medical support for clinical development, including responses to regulatory agency queries
To ensure that GCPs, Ethics, medical compliance is applied within all clinical development activities. The incumbent is accountable to the CMO
Main Duties to be performed:
? Under the direction of the designated Therapeutic Area Head and in close collaboration with key stakeholders, to medically monitor clinical development programs deployed in China
? To provide medical expertise and lead as required :
- documentation including but not limited to the IB, clinical summaries, response to queries from the regulatory authorities, clinical study synopses and protocols, in line with clinical development plan,
- discussion and conclusion on Clinical Study Reports and to ensure the coherence on the interpretation of the data through the clinical development plan in line with the target product profile
? To monitor & facilitate the conduct of clinical studies, to alert the project team to any safety issues which may have a potential impact on the clinical development of the product or its target market
? To inform the Clinical Development Therapeutic Area Head with up to date project status reports
? To be co-responsible with clinical operations of clinical trials and proactively identify potential problems of a clinical nature that might have a deleterious effect on a program’s timely completion and report these to the project team
? To propose upon consultation with clinical operations pragmatic solutions to insure the efficient ethical & quality conduct of clinical trials
? To establish and maintain professional relationships between the company, external medical experts and key opinion leaders and to represent Drug Development at investigators’ meeting or expert panels as required
? To provide tactical support as required on Joint Development Committees and Due Diligences
? To proactively liaise with the Translational Sciences group and Franchises to inform them about the progress of the clinical development program, to help them to evaluate potential business risk
? Generic and Managerial responsibilities :
> Perform any other activity that may reasonably be required from time to time.
> Complete all of the above activities within the framework and in compliance with the R&D SOPs and other documentation in force in the Ipsen Group.
> Develop and maintain state of the art scientific and medical knowledge through strong external professional network
> Be an active member and contributor to Ipsen’s medical community
Specifics of Position:
Significant international travel required
Education:
- Ideal: Post graduate professional qualifications required in addition to Medical qualifications (equivalent in UK of Membership of Royal College of Physician or Fellowship of Royal College of Surgeons)
- Minimum: Medical degree
- Languages: Chine - English
Experience (Proficiency):
- Ideal: At least 5 to 8 years clinical development experience
- Minimum: Substantial experience in pharmaceutical drug development
公司介绍
任仕达（Randstad）是全球最大的人力资源服务机构之一，1960年由创始人Frits Goldschmeding 先生在荷兰阿姆斯特丹正式成立。经过长达５０年的持续发展，任仕达集团全球营业额超过２００亿美金，位列２００９《财富》杂志５００强的４５０位。
任仕达中国的业务范围包括： 招聘与猎头、弹性用工、人力资源外包。我们已经为数千家中国地区的跨国企业、民营机构以及国有企业提供专业服务，并在金融服务、电信、快消品、零售、ＩＴ、化工与制药等领域树立了领导地位。
我们的使命是充分关注求职者能力发展与客户业务发展的需求，并将两者完美匹配起来，通过持续创新和及时响应客户和求职者不断变化的需求，我们始终将服务水准保持于至臻境界。
现今的商业环境，竞争愈发激烈，变化转瞬之间，因此对于劳动力的灵活性、生产力水平的提高以及与人力资源相关的外包服务需求也随之不断增加。为了更好的满足这些需求，我们提供从人事管理到高管搜寻、几乎覆盖人力资源服务各个方面的全方位解决方案。
在中国这个不断变化的市场中，任仕达成功将其在国际市场上积累的丰富经验与对本地市场的深刻了解相结合。因此，我们能够满足客户在人力资源方面的全方位需求。
优秀的人才是我们成功的基石之一。我们为员工提供广泛，多样化的培训和职业发展机会和具有竞争力的薪酬。我们真诚期待您的加入。
任仕达中国的业务范围包括： 招聘与猎头、弹性用工、人力资源外包。我们已经为数千家中国地区的跨国企业、民营机构以及国有企业提供专业服务，并在金融服务、电信、快消品、零售、ＩＴ、化工与制药等领域树立了领导地位。
我们的使命是充分关注求职者能力发展与客户业务发展的需求，并将两者完美匹配起来，通过持续创新和及时响应客户和求职者不断变化的需求，我们始终将服务水准保持于至臻境界。
现今的商业环境，竞争愈发激烈，变化转瞬之间，因此对于劳动力的灵活性、生产力水平的提高以及与人力资源相关的外包服务需求也随之不断增加。为了更好的满足这些需求，我们提供从人事管理到高管搜寻、几乎覆盖人力资源服务各个方面的全方位解决方案。
在中国这个不断变化的市场中，任仕达成功将其在国际市场上积累的丰富经验与对本地市场的深刻了解相结合。因此，我们能够满足客户在人力资源方面的全方位需求。
优秀的人才是我们成功的基石之一。我们为员工提供广泛，多样化的培训和职业发展机会和具有竞争力的薪酬。我们真诚期待您的加入。
联系方式
- 公司网站：http://www.randstad.cn/index.aspx
- 公司地址：上海市长宁区遵义路100号虹桥上海城A座1601-1605
- 邮政编码：200051