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[北京]百济神州(北京)生物科技有限公司

  1. 发布时间:2020-01-17
  2. 工作地点:北京
  3. 职位类型:全职
  4. 来源:前程无忧(51JOB)
  5. 职位:Medical Writing Specialist 医学撰写专员(北京)
职能类别:其他

Responsibilities:
? Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents
? Develop and manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
? Ensure clinical documents adhere to BeiGene standards and regulatory guidelines
? Ensure that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles
? Ensure the key messages as defined by the team are clearly and adequately represented in the documents; drive the team to reach agreement in case of conflicting opinions.
? Establish effective cross-functional communication and relationships with counterparts both internally and externally.
? Participate in departmental or interdepartmental process improvement and training initiatives.
Requiremnts:
? Minimum requirement of a master’s degree of life science/pharmacy/ nursing/medical/health related science or equivalent; PhD/PharmD in life sciences preferred
? Prefer with relevant industry experience as a regulatory medical writer
? Demonstrated ability to communicate and write English clearly, concisely, and effectively
? Good interpersonal skills; a team player
? Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member
? Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner
? Ability to complete high-quality documents according to tight timelines
? Ability to comply with company and/or industry style guides and templates
? Good project management skills
? Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems


公司简要介绍:

公司名称:百济神州(北京)生物科技有限公司
公司类型:上市公司
公司介绍:百济神州是一家植根中国的全球性商业化生物制药公司,致力于成为分子靶向药物和肿瘤免疫药物研发领域,以及商业化创新领域的全球领导者。
我们拥有行业领先的自主研发能力和丰富的产品管线。包括10款在研管线药物,其中6款由内部自主开发,3款已进入临床后期。我们是首家在中国和全球范围同步开展注册性临床试验的创新药企之一,目前在5大洲开展临床试验。
我们专注质量,建设符合国际标准的生产设施。我们于2017年在苏州建成可生产商业规模小分子药物和临床规模生物制剂候选药物的生产基地,目前正在广州建设用于生产商业规模大分子单克隆抗体类抗癌药的生物药生产基地。
我们持续打造商业化运营能力。2017年,我们成功过渡为商业化阶段公司,并吸纳行业优秀人才,不断壮大商业运营团队。
我们是首家在纳斯达克和港交所双重一级上市的生物科技公司之一。


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