南京招聘

General Summary

Researches, writes, and edits clinical documents, including clinical study reports, clinical study protocols, clinical plan outlines, sections of regulatory submission documents, and scientific manuscripts by applying therapeutic expertise and clinical drug development knowledge and relevant experience to the development of drugs, biologics, devices and or other products for human use. May provide writing support for more complex clinical documentation, with appropriate departmental supervision. May serve as primary technical contact with client.

Accountabilities

· Writes, reviews, and edits scientific manuscripts, clinical study reports, plan outlines, protocols, documents for regulatory submissions, investigator brochures, posters, newsletters, or other clinical and regulatory documents

· Interprets non-clinical and clinical data in the preparation of various technical reports

· Perform literature searches and reviews

· Leads project teams in drafting individual report specifications, medical writing, and coordination of data analysis

· Schedules and conducts peer and team quality control review for assigned projects

· Serves as primary functional representative on project teams

· Provides both in-house and outside consulting services

· Reviews all relevant documents and interacts with functional leader and project manager to develop a thorough understanding of project timelines

· Contributes to clinical protocol development

· Performs other tasks as directed by the line manager

Qualifications

· A post graduate degree from an accredited institution in Life Sciences or Health-related Sciences, or equivalent

· Science or medical related writing experience required

· Familiarity with medical terminology

· Experience using computerized systems (PC-Windows and MS Word)

· Excellent written, oral communication and presentation skills

· Fluent in English reading, writing and speaking

· Pharmaceutical company or CRO experience developing pharmaceutical drugs for human use (e.g. pre-clinical science, medical related writing, clinical trials management, monitoring, or as an investigator or study coordinator for clinical trials)

· Experience in clinical study design and protocol development/writing

· Knowledge of regulatory submissions requirements, ICH clinical study report writing guidelines

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务，包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册，通过严格的质量控制体系和专业团队的丰富经验，帮助创新性，突破性医药产品尽快上市和造福患者。

康德弘翼立足中国，面向世界，以上海总部为中心，辐射全球制药公司、生物技术公司以及医疗器械公司。目前，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系，始终保持着紧密的业务交流，保证了项目能高效、高质地完成。

随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。