北京招聘

Responsibilities：
1. Be responsible for writing, editing and reviewing of clinical study reports (China country CSR), and other clinical regulatory documents such as clinical overview (M2.5) and summary (M2.7), RCP for China IND.
2. Act as the process driver for BB (Briefing Book) and slides preparation for China CDE meeting, BTD application documents, etc..
3. Understand China guidelines/requirements for clinical regulatory documents and Explain to global medical writing team for well understanding.
4. Coordinate and conduct cross-functional team review and deliver documents according to relevant guidelines/SOPs, including distributing drafts, chairing round table meetings, incorporating revisions, and completing the sign-off procedures.
5. Perform quality control review (QC work) such as copy editing, content editing, and number checking for other writers as required locally and globally.
6. Accept the medical writing and review task assignment from global team, and drive the process as the author or reviewer under global SOP frame
7. Take the oversight role for outsourced medical writing activities.
8. Support response to CDE query or deficiency requirement in case related to medical writing contents.
9. Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members.
10. Applies evolving knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Participates as part of the medical writing team in cross-functional team (agenda driven).
11. May assist in development of formats, templates, and general guidelines for clinical documentation and workflow procedures.

Qualifications：
1. Master Degree or above, major in Medicine, Clinical Pharmacology, Basic Medicine related subjects;
2. 5 years or above regulatory medical documents writing related experience in Pharmaceutical Company or CRO; Prefer to have the experience of oncology related medical writing for NDA submission.
3. Fluent English listening, speaking, reading and writing;
4. Have basic knowledge of biostatistics and pharmacokinetics
5. Good communication and expression skills; good organization and coordination skills;
6. Familiar with the use of Microsoft office;

第一三共制药（北京）有限公司是由第一三共株式会社及第一三共（中国）投资有限公司出资在北京经济技术开发区建立的外商合资企业，现投资总额已达25,140万美元。第一三共制药（北京）有限公司作为生产基地，主要生产品种有泰利必妥？片剂、可乐必妥？片剂、可乐必妥？注射剂、优利福？硬胶囊剂。
场区占地面积约为4.8万平方米，建筑物占地面积约为1.3万平方米。
为满足不断扩大的注射剂市场的需求，2012年8月投资2,000万美元开始软袋生产线暨管理栋（含试验室）工程建设，2015年4月完工，目前正在开展试运行的各项准备工作。
作为第一三共集团的一员，遵循集团宪章的方针，秉承“创新、诚实、激情”三个精神，基于向社会做出的八项承诺，开展各项业务。全体员工将不断努力工作，在“激情创新、真情为您”的企业口号感召下，通过不断变革提升质量管理体系，改善产品生产过程，以客户为导向，保证产品质量，提高服务水平,使我们的产品为提高人民的健康幸福做出贡献。