北京招聘

Responsibilities:

Will be responsible for development of medical writing deliverables that support the clinical regulatory writing portfolio and scientific publication works with guidance and oversight to achieve goals.  In this role the Medical Writer:

·         Is recognized as a scientific contributor in preparation of selected regulatory clinical documentation and scientific publication.

·         Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Participates as part of the medical writing team in cross-functional teams (either internally or externally).

·         Contribute to the planning, preparation of scientific publications involved in clinical development process, including academic papers, conference posters/abstracts, etc.

·         Demonstrates competence in writing, editing and reviewing of clinical study reports, clinical overview, clinical summary and other clinical regulatory documents in line with expectations. Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.

·         With supervision, manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings. Works collaboratively with colleagues across functions to achieve results.

·         Supports the medical writing team with quality control, editing, and coordination activities, as needed.

·         Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members. 

·         May participate in orientation and coaching of junior team members or contractor writers.

·         May participate in initiatives to improve medical writing processes and standards.

·         Ensures the high quality translation of clinical documents before due date. Archive all validated documents and signed forms. Manage translation vendor to improve their quality of delivery. Explore new technology to improve the translation quality and efficiency.

·         Maintains IB, protocol and CSR templates and provide training to newcomers.

 

 

Requirements

 

·         Degree in the Life Sciences, Medicine or related.  

·         Bachelor’s degree with 4~5+ years; or MS with 3+ years; or PhD with 2+ year of relevant career experience.

·         2~4 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry. Ability to prepare, with supervision a subset of clinical regulatory documents (e.g., CSR, IB, protocol, safety narratives) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.

·         Participate actively in medical writing and cross-functional project teams.

·         Technical expertise in Microsoft Office, document management systems, and familiarity with SharePoint and concepts of structured content management.

·         Excellent oral and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.

·         Fluent in Chinese and English (reading/writing/listening/speaking).

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.