北京招聘

职位描述：
Responsibilities
1. Perform quality control on all documents received per In-line QC checks and other reference documents.
– Demonstrate understanding on document types, properties and indexing requirements
– Ensure overall TMF quality by checking document completeness, indexing and scanning accuracy
– Process documents in the TMF system(s) within specified timelines, based on document criticality/priority
– Communicate document inquiries with responsible users as needed
2. Liaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issues
Communicate, escalate issues to the TMF Document Specialist Lead and TMF Operations
3. Contribute to process improvements and additional special projects that may arise
4. Can be identified as a Subject Matter Expert where applicable

Qualifications:
1. Bachelor’s degree or above. Pharmacy or Medicine related preferred.
2. Good English verbal and written communication skills.
3. Knowledge of the principles and practices of traditional and electronic records management as applied to the pharmaceutical or related industry
4. Attention to detail evident in a disciplined approach to document maintenance and management
5. Experience/knowledge of ICH/GCP documentation requirements
6. Ability to work both independently and within teams; show respect and support for all team members 举报 分享

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。