南京招聘

Primary Purposes of Position:

1. Provide clerical support for clinical trials according to Ipsen Standard Operating Procedures (SOPs).

2. Provide full support in clinical trials documents management to study teams during the preparation, conduction and close-out of clinical trials.

3. Maintain administrative systems, e.g. HERMES (tracking and other) for clinical trials according to Ipsen SOPs.

4. Assume a coordinating role for the project team concerning administrative and financial matters.

Main Duties to be performed:

l Organize, maintain and complete the paper or electronic study master files including collation of study documents from monitors or CROs and appropriate filing of documents. Identify, request and ensure delivery of outstanding and outdated documents. Identify and prepare documents to the study sites or for regulatory submissions as needed. Periodically and at the end of the study, review study files for organization and for completeness.

l Review the pre-audit, pre-inspection or pre-archiving of the study files to ensure their quality and completeness.

l Support clinical related meeting’s logistics. Order venue, arrange transportation, prepare meeting binder, communication with organizing vendor, etc.

l Support clinical supply/ non- clinical supply shipment, customs clearance, receiving, distribution, collection and destruction. Keeping related record and documentation.

l Storage room maintenance. Keep good condition of storage room, such as temperature, moisture. Keep the access control to related people.

l Equipment maintenance and accreditation. Help clinical research staffs purchasing the clinical study related equipment.

l Vendors coordination, study contract and payment coordination (Financial support & invoice tracking of all study budget).

l Perform various study related functions as required and assigned to ensure the accurate, quality and timely execution of clinical studies.

l Work with other medical/marketing/sales function staffs for any clinical trial related activities.

l Perform any other activity as may reasonably be required from time to time.

l Complete all of the above activities within the framework and in compliance with Ipsen SOPs and other documentation in force within the Ipsen Group.

Specifics of Position:

l An understanding of the clinical study process

l Good communication skills with customers

l Detail focusing

l Have the relevant financial knowledge

益普生集团是一家专注在药物创新和肿瘤病学、神经科学以及罕见病学领域的国际生物制药公司。我们有完善和成功的消费者保健业务，始终致力于通过发现新的疾病解决方案来提高患者的生活质量。从家族企业到上市集团，我们已经走过90年的历史，益普生集团拥有20种产品，销往网络遍布于115个国家，并在其中30多个国家直接设立了商业公司。2019年的总销售额超过25亿欧元，其中在欧洲达到了两位数的增长，在北美增长了20%。我们专注于以Decapeptyl？为代表的肿瘤病学、Dysport？为代表的神经科学以及罕见病学为主导的专科疾病领域，且在多元健康业务领域也有卓越表现。目前我们在全球范围内拥有逾5700名员工，建立了8家研发中心和8个生产厂。值得骄傲的是，2018年我们将13.5%的销售额投入到研发。在肿瘤病学领域，我们是全球排名前14的生物制药公司。

1992年，益普生进入中国并在天津成立代表处开展业务，随后于1997年在天津华苑产业园区成立合资企业博福-益普生（天津）制药有限公司。经过了逾23年的稳健发展，中国已经成为益普生集团在全球范围的第二大市场。随着益普生集团整体发展战略的清晰化，特别是随着销售额和市场需求的不断攀升，2015年5月益普生（天津）医药商贸有限公司在天津成立。2010年4月，益普生（北京）医药商贸有限公司在北京成立，2020年4月益普生（上海）成立。

在中国，益普生借助其明星产品思密达成为了消化领域的领导企业，并且力争成为专业治疗领域内的领军者。益普生近期在中国所进行的Somatuline？和Dysport？的临床实验也推动了在专科领域特别是内分泌和神经领域的快速发展。另一个见证益普生在专科领域蓬勃发展的案例就是泌尿肿瘤类药物Diphereline？，一种服务于前列腺癌患者的领先药物。