北京招聘

Responsibilities:

·         Participate the QC plan development of a clinical research project and ensure QC plan developed/executed properly in according with regulations/laws and company requirements.

·         Prepare and conduct QC tasks per agreed QC plan , such as Conduct co-monitoring per QC plan, mentor and coach CRA when applicable;

·         Reflect the issues and lead the further discussion and CAPA if necessary cross functionally.

·         Provide compliance support by answering questions or providing advice on GCP, SOPs, regulations and guidelines and bring issues to the attention of Clinical Operations Head as appropriate.

·         Support Clinical Operations team in preparing for sponsor audits and provide input into the generation of timely and appropriate audit response plans and assisting in preparation and responses for regulatory authority inspections

Requirements

 

·         Bachelor (or above) degree in life sciences, pharmacy, nursing or medical. At least 5 years’ experience in clinical trial operation or project management preferably experiences in a role equivalent to GCP audit/QC specialist.

·         Proficient knowledge of ICH GCP and associated regulatory guidelines.

·         Proficient English skills in listening, speaking, reading and writing.

·         Excellent verbal and written communication skills, interpersonal skills

·         Good ability to establish and maintain effective working relationships with coworkers, managers and clients/customers.

·         Demonstrate effective coaching/leadership/supervisory ability.

·         Good organization, logical thinking, problem solving and presentation skills.

·         Ability to travel frequently.

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.