北京招聘

职位描述：

Key Accountabilities
Write documents for submission to FDA, including but not limited to: independent review charters, acquisition guidelines, reviewer training manuals, protocols, Case Report Forms (CRFs), and other documents required by Perceptive SOPs.
Write any of the clinical documents associated with drug or device applications to regulatory bodies. Write documents associated with clinical trials, which are not necessarily part of regulatory submissions, including but not limited to: study manuals, CRF completion instructions, articles and manuscripts
Coordinate and conduct interdivisional team review and document deliverables according to Perceptive guidelines/SOPs, including distributing drafts, chairing round table meetings, incorporating revisions, and completing the sign-off procedures.
Perform quality control review such as copy editing, content editing, and number checking for other writers as required.
Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents.
Review analysis plans to assist in determination of appropriateness of content/format for clinical writing.
Attend internal technical team and client team meetings as required.

Serve as Medical Writing representative on assigned Project teams.
Regularly communicate project related issues with the Associate Director Medical Writing and the project team, as appropriate.
Assemble client deliverables to be filed appropriately in Central Files and project archives.
Adhere to ICH, FDA or other appropriate regulatory body guidelines with respect to document content and style, and compliance with departmental guidelines and corporate SOPs.
Meet client expectations by following any templates, styleguides, or SOPs provided by the client for document development (within the appropriate regulatory guidelines).
Keep abreast of professional information and technology through workshops and conferences.
May assist in development of formats, templates, and general guidelines for clinical documentation and workflow procedures.
May participate in departmental or interdivisional process improvement and training initiatives.
May provide guidance to junior staff members.

Skills
Excellent written and oral communication and interpersonal skills, and knowledge of the drug development process essential; strong word processing skills, familiarity with Microsoft Word for Windows.

Education
Bachelor's degree in Life Sciences/Health Related Sciences (minimum)

Language Skills
Fluent in English

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精鼎医药（Parexel International）是全球领先的药物研究合同委托机构（CRO），总部位于美国生物医药圣地马萨诸塞州的波士顿附近，在世界各地拥有71个办事处，约17,600 名员工，为超过100个国家的客户提供服务。

精鼎医药成立于1982年，在三十多年的历程中，一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商，并且取得了卓越成果。目前，我们能够提供全世界CRO领域全面的新药临床阶段研发服务，服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。

将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案，可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。