北京招聘

Description / Scope:

To manage allocated study (ies) and study site(s) to ensure product accountability, delivery, process timelines and quality standards are met. 

 

Specific Responsibilities includes and not limited to:

a)      Maintenance of IMP accountability documentation

b)     Archives IMP related documentation into eTMF or Trial Master File

c)      Provides logistic support to CO team for the IMP availability and distribution to ensure smooth execution of the study

d)     Responsible for the processing of IMP request to supply for study, for country specific and also site specific

·        To ensure compliance of each country(ies)’ import and export regulations.  This includes obtaining of local required licenses or permits

·        Oversee CRO vendor that is responsible for ensuring deliverables if process is outsourced.

e)      Liaise directly with CMC colleagues for the following:

·        Updated re-test date and extension memo for specific IMP

·        Availability of GMP certificate for specific manufacturing site.

·        Ensure sufficient supply and forecast of required supply

f)       Coordinate the process and including obtaining appropriate and correct IMP labelling approval

g)      Assist with the process for re-labelling of IMP should re-test or extension date be needed.

h)     Actively involved with the selection and oversight of vendor responsible for the deliverable of an IRT system (if applicable).

 

Requirements:

1.      College graduate, preferably with a healthcare or life science degree.

2.      Good knowledge of ICH-GCP, GCP and local clinical trial regulations.

3.      Basic computer skill (MS Office, Internet, etc) .

4.      Ability to work independently and as part of a team.

5.      Self-initiative to perform duties, with good analytical and problem-solving capabilities.

6.      Ability to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervision.

7.      More than 2-year experience of working in a clinical trial environment.

8.      Fluent English in oral and writing.

和铂医药是一家专注于肿瘤免疫领域创新药物研究与开发的全球化运营生物医药公司。公司将运用其拥有的全部自主知识产权的全人源单抗的转基因鼠系列核心技术平台，建立下一代治疗性肿瘤抗体药物产品管线,并将围绕Harbour的两大平台拓展合作与授权业务。公司总部及研发基地位于中国上海，另外在美国马塞诸塞州剑桥设立商业运营中心，在荷兰鹿特丹设立抗体研发平台创新中心，在波士顿地区设立了创新中心包括实验室和研发团队，也将在江苏昆山设立研发基地。公司拥有资深管理团队以及丰富的药物研究与开发经验。和铂医药要为满足中国及全球病人的需求而不断努力，依托拥有自主知识产权的核心技术平台,创建一个在肿瘤治疗领域有科学与技术领导力的国际性生物医药公司。同时, 在药物研发领域建立以技术平台为基础的对外合作，整合新的技术，推动中国整个抗体研发产业的进步。

Company Overview
Harbour BioMed is a global biotechnology company discovering and developing innovative therapeutics for cancer with a focus on immuno-oncology and autoimmunity/inflammation. The company's discovery and development programs are centered around its two patented transgenic mouse platforms for human antibody discovery.
The company is building its proprietary pipeline internally, through collaborations with co-development partners, as well as through selective preclinical and clinical stage asset acquisitions. Harbour BioMed also licenses the platforms to companies and academic institutions through its Harbour Antibodies subsidiary.
Harbour BioMed has headquarters and an R&D site in Shanghai, business operations in Cambridge, MA, and antibody platform development in Rotterdam, The Netherlands.
The company has an innovation center including research lab and a development team in Boston. Also, we are expanding to Kunshan site in Jiangsu for our R&D operation.