1. 负责根据GMP、SOP要求，对药品生产过程进行巡检，并对成品进行取样，保证药品生产过程符合GMP要求；2. 部门内所需了解法规、FDA以及MHRA等警告信的翻译汇总；3.工艺用水和工艺用汽取样等。

(1) Assist the operation of clinical trials in EU & US, including literature review, clinical data check like subject visits records, archiving of related documents etc;(2) Lead and participate in the contracting process with CRO, PV, and other vendors to be involved in CTs;(3) CTS related work, such as drafting the packaging order & IMP labels, shipment of clinical samples and internal communication with related depts.;(4) Review vendor invoices, take care of the payment process… Show more (1) Assist the operation of clinical trials in EU & US, including literature review, clinical data check like subject visits records, archiving of related documents etc;(2) Lead and participate in the contracting process with CRO, PV, and other vendors to be involved in CTs;(3) CTS related work, such as drafting the packaging order & IMP labels, shipment of clinical samples and internal communication with related depts.;(4) Review vendor invoices, take care of the payment process and do summaries;(5) Submit and manage monthly and annual project budget;(6) Accompany my boss to attend quarterly meetings of the Group;(7) Other daily administration work. Show less

I worked in the Global Health Business of Oriental Ocean and took the following responsibilities:(1) translation of publicity materials of Global Health Business(2) translation of manufacturing directions and clinical files related to in vitro diagnostic reagents, such as HIV and HTLV assay(3) translation of products’ instructions for use and other relevant materials commissioned by all subsidiaries of the company (9 subsidiaries), such vitamin D assays;(4) translation of SOP… Show more I worked in the Global Health Business of Oriental Ocean and took the following responsibilities:(1) translation of publicity materials of Global Health Business(2) translation of manufacturing directions and clinical files related to in vitro diagnostic reagents, such as HIV and HTLV assay(3) translation of products’ instructions for use and other relevant materials commissioned by all subsidiaries of the company (9 subsidiaries), such vitamin D assays;(4) translation of SOP procedures and files;(5) translation of CE mark and FDA approval application materials;(6) advertising materials of the sales company;(7) receptionist and interpreter for foreign guests;(8) interpreter for negotiation meetings of the company and government;(9) interpreter for technicians and researchers when they study abroad. Show less

(1) translation and proofreading of medical papers commissioned by the company; (2) translation of publicity materials and contents of official website; (3) interpreter and assistant for lecturers and guests invited by the company; (4) organization and projecting of training workshops for hospitals (having planned 52 workshops in total); (5) acting as business manager from June to September, 2014 and responsible for coordination and negotiation of projects with hospitals;… Show more (1) translation and proofreading of medical papers commissioned by the company; (2) translation of publicity materials and contents of official website; (3) interpreter and assistant for lecturers and guests invited by the company; (4) organization and projecting of training workshops for hospitals (having planned 52 workshops in total); (5) acting as business manager from June to September, 2014 and responsible for coordination and negotiation of projects with hospitals; (6) stop acting as business manager due to further study program (2014-2016), but still work as full-time translator and workshop organizer for the company. Show less