-
5-7年经验 -
硕士 -
招1人 -
01-03 发布
- 五险一金
- 补充公积金
- 员工旅游
- 专业培训
- 年终奖金
- 弹性工作
- 定期体检
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 职能类别： 生物工程/生物制药 关键字： Medical Writer, CRO
联系方式
朝外大街乙12 號昆泰國際大廈11樓1115室
公司信息
精鼎医药研究开发(上海)有限公司(PAREXEL International)，成立于1982年，是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国，分支机构遍布欧、美、亚、大洋四大洲，且于亚洲13个国家和地区设立了分支机构，致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成，服务团队集合各种不同专业领域的人才。我们重视与客户的承诺，更重视人才的培育和养成，我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境，期许同仁与公司一同成长，迈向未来。 愿景（Vision）： 创造一个在亚太地区具有国际竞争力的最精良CRO团队。 发展使命（Mission）： 1．争取国际大药厂委托，执行符合国际水准的跨国性临床试验。 2．协助亚太生技及制药产业建立新药开发模式，以提升产品研发能力，幷促使产品国际化。 3．以提升临床试验品质为宗旨，拓展全球市场为目标，整合计算机及通讯科技，在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。 4．建立一个以亚洲人种高发生率疾病的基因数据库，以提供国际性新药研发机构所须之基因信息，协助其缩短药物开发时程，幷提高研发成功率。 公司福利和人才培养计划： 保险类： 1. 社会保险(依照国家规定)及住房公积金； 2. 团体保险（包括寿险、意外暨医疗保险）； 3. 补充医疗保险； 制度类： 1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣，设计符合其个人之生涯规划； 2. 完整的教育训练：每年公司均针对所有员工，提供完整之教育训练； 3. 顺畅的升迁管道及可转调其它部门；如有职缺，亦可申请调至海外各子公司； 请 / 休假制度： 1. 服务第一年即享有14天年假, 后续年休假天数则依据服务年资及公司制度而定； 2. 一年可享12天不扣薪病假； 3. 员工旅游, 年度体检； 精鼎医药将以培养国际性的人才为目标，欢迎具有国际观之人才加入。 应聘方法： 1. 在线投递； 2. 请登录我们的公司网站直接投您的简历（https://jobs.parexel.com/search-jobs） 我们在收到您的简历之后，会尽快与您联系。 谢谢！
