南京招聘

GENERAL SUMMARY
Provides medical expertise for site identification, study feasibility, study design, conduct, analysis and reporting, generation of integrated databases, pooled analyses for efficacy and safety, IAE and IASs, dossiers for regulatory submissions for market authorizations of new medicinal products, and diagnostics and devices. Also may assist Business Development group in tasks related to marketing and selling PRA services.

ACCOUNTABILITIES
Provides medical expertise on drug development and, benefit/risk evaluations throughout life-cycle of compound
o Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material, selection, and recruitment of investigational sites
o Provides continuous medical monitoring during study conduct, answering site questions on inclusion/exclusion criteria or other protocol questions, evaluation of SAEs and AEs, review of laboratory and other patient’s data, review of codes for medical history, concomitant diseases and medications, adverse events, and provides medical expertise to project team during life-cycle of study
o Assumes responsibility for ethical, e.g. medical, aspects of study
o Leads and/or contributes to discussions with regulators and/or investigators, opinion leaders, internal and external clients, and project team support
o Supports the feasibility group in developing feasibility plan and questionnaire, in determining type of investigational sites and in selecting countries and sites. Reviews feasibility results and report.

Supports generation of publications and expert reports
o Reviews and interprets study results and reports
o Generates expert reports and supports IAS/IAEs , NDAs/PLAs, and other regulatory submissions as well as generates and/or reviews publications, posters, and scientific presentations
o Evaluates spontaneous reports and literature cases, provides individual and cumulative benefit/risk assessments, communicates with reporting health care professionals, experts and consumers, reviews and authorizes Periodic Safety Update Reports, evaluates safety issues, designs and/or leads investigations, recommends interventions to clients, and contributes to hearings at regulatory agencies and/or court

Develops and provides training
o Provides therapeutic training relevant to specific study to project team, attends and/or presents at Investigator, internal and external project team meetings
o Develops and implements training for PMs, CRAs, CSAs, CDCs, STATS, AP, DP, medical monitoring associates, medical writers; serves as an active mentor to one or more junior staff members and provides formal in-service training as requested by the functional leader; serves as a mentor/expert for new employees

Supports Business Development by providing medical expertise to identify, acquire, and win new business
o Builds relationships with new customers, maintains client relationships to obtain repeat business, identifies new business opportunities through contacts, literature, and conferences
o Promotes PRA through active involvement in scientific meeting, and speaking engagements
o Contributes to RFPs by identifying critical success factors and providing options for different approaches for patient recruitment, referral systems, and operational execution
o Attends bid defense meetings including generating presentations and, takes active role in RFP discussions with clients
o Supports BD in client contacts to discuss portfolio and development strategies

QUALIFICATIONS
? Licensed physician
? Clinical practice and/or clinical research or drug safety experience preferred
? Experience writing pharmaceutical or health-related documents required
? Experience writing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal preferred
? Knowledge of regulatory requirements preferred
? Good communications skills required
? Project leadership/management skills preferred
? Experience using computerized systems (PC-Windows and MS Office)
? Read, write, and speak fluent English; fluent in host country language

 十一年前，药明康德的创始人李革博士肩负着“变革新药研发、造福人类健康”的人生理想，创立了药明康德；如今，药明康德已成为在中美两国拥有5600余名员工、中国首屈一指、全球领先的医药研发外包服务供应商，在全球九大城市拥有运营实体，客户囊括全球制药巨头前二十。作为国内医药研发服务的领头羊，药明康德无疑是卓越的医药研发平台，并继续致力于打造创新型的、全方位一体化的研发服务平台。
    药明康德绝不停留于自身的卓越。药明康德的血液里一直流淌着“爱才惜才”的文化，让每一位员工“从优秀到卓越”，给每一位员工一个“精彩的人生理想舞台”，更是公司一直所追寻的企业文化和宗旨。药明康德将引领你进入世界级医药研发的殿堂，在你实现人生理想的征途上，激励护航。
    我们的人才—既有曾服务于辉瑞、礼来、默克等世界制药巨头的科学家，也有大批从校园毕业后直接进入药明康德工作并脱颖而出的优秀人才。
    我们的客户—集中于欧美国家的国际知名制药、生物制药和医疗器械公司。
    我们的设备--世界一流水平的研发生产设备设施是我们高效率、高质量、高标准的基本要求，也是确保我们的员工掌握世界最前沿技术的第一保证。
    海阔凭鱼跃，天高任鸟飞，你的才华在药明康德可以展现；你的梦想在药明康德可以实现，我们将为你铺就走向闪耀人生的成长之路！这里，是卓越的药物研发平台，更是精彩的人生理想舞台。
 
    药明康德将为您提供：
    更全面的薪酬福利体系----工作生活的最佳平衡
    更加丰富的文化升华----拉近你我心的距离
    更完善的培训机制----不断提高综合素质，帮助我们全面成长
    更多职业发展空间----竞争和挑战我们积极面对
    
    怀揣梦想，带上热情，加入药明康德，未来的篇章由你尽情书写。
 
 
近期荣誉和奖励
2011年药明康德入选"2011年中国服务外包十大领军企业"
2011年药明康德董事长兼首席执行官李革博士荣膺"2011中国服务外包杰出贡献人物”
2010年药明康德苏州毒理中心获得由国家食品药品监督管理局（SFDA）颁发的优良实验室管理规范（药物非临床研究管理规范）（GLP）证书
2010年药明康德苏州毒理学中心获得经济合作与发展组织GLP认证
2010年药明康德上海合全药业荣获由SGS颁发的ISO14001证书
2010年药明康德苏州毒理中心荣获国际实验动物评估认证管理委员会 (AAALAC) 的国际认证
2004，2005，2006，2007，2008以及2009年连续六年荣膺“德勤亚太地区高科技高成长500强”
2005，2006，2007，2008以及2009年连续五年荣膺“德勤中国高科技高成长50强”
2009年荣获“第七届中国大学生医药行业十佳最佳雇主”
2009年荣获“中国十大服务外包领军企业”
2009年荣列《快速杂志》“世界最具创新力企业年度50强”