长沙招聘

职位描述：
Therapeutic Area responsibilities:

1/ Strategic Responsibilities

– Serve as the GCO Lead in related China Compound Teams to provide functional input and expertise to the development of China compound strategy to achieve optimal efficiency and effectiveness in clinical program development & execution

– Serve as the liaison of local TA (Clinical Development), and some other functions of China R&D

– Serve as the primary contact for RTAE and possibly for CPL, for trial planning and management and other related development activities in China

– Build strategic relationships with network of investigators

– Find and develop new investigational sites

– Support local training on disease areas and protocol, as appropriate

2/ Operational Responsibilities

– Strong interaction with China R&D China Compound Team (CCT) members, Commercial and departments within GCDO and outside of GCDO, i.e., GCDO- GPL and GTL), GCDO-MAO, Regional Therapeutic Area Expert (RTAE), Integrated Data Analytics and Reporting (IDAR), Clinical Supplies Unit (CSU), Quality and Compliance (QC), and external partners such as KOLs, Academic Centers, Investigator Networks, external vendor groups etc.

– Early input in protocol design for China (do-ability)

– Propose China specific recruitment plan for both global trials as well as China along trials (feasibility)

– Follow up on trial performance versus China plan and trigger mitigation actions in collaboration with GTL/CTM or/and RTAE and LTMs

– Responsible for project planning and support for study execution and monitoring

– Support Site inspection and Audit readiness if needed

– Ensures all operational objectives are met in conformance to all relevant ICH-GCP regulations, guidelines including Health Care Compliance, and internal SOPs, Work Instructions, and Policies

– Support Clinical Trial Head in related Therapeutic Area(s) in managing and developing LTMs, and may support the LTMs in managing new trials in China, if needed

– Collaborates with the RTAE on country capabilities and study placement for assigned Therapeutic Area(s) or study portfolio.

– Accountable for study feasibility in country for assigned Therapeutic area or study portfolio.

Functional Management responsibilities:

– Take the role of line management of a team of SMs (Site Managers)

– Evaluates and projects resource needs for assigned portfolio, and liaises with local GCO management for resource requests as appropriate.

– Interviews, hires, develops and trains staff

– For employees: Responsible for performance and development in accordance with the Performance Management

guidelines, including talent development, coaching, mentoring and providing ongoing performance assessment

– Ensures staffs have a clear understanding and knowledge of GCO SOPs, Work Instructions and Company Policies supported by documentation of training compliance in Learning @ Pharma R&D, Summit or applicable training documentation systems.

– Supports staff in communications with Ethics Committees, Health Authorities, Investigational Sites and groups external to GCO

– Coaches staff in their role in local Health Authority site inspections and follow-up activities including CAPA generation

– Appropriate and timely issue escalation to line management and study team as appropriate. Report (suspicion) of fraud or scientific/ethical misconduct.

– Communicates with staff on program changes, policy changes and priority shifts

– Conducts Accompanied Site Visits with Site Managers

– Review and approve expenses; assure expenses are in compliance with the company’s policies.

– Demonstrate Leadership Behaviours in alignment with Leadership Imperatives

– Fosters an environment that encourages the sharing of ideas, information, and best practices (internal and external to the organization)

– Participates in special initiatives as needed and guides rollout of new processes and procedures

– Supports metrics review and necessary follow-up actions

Qualifications

Minimum Bachelor's degree in Clinical Medicine or Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy), higher degree is preferred.

Minimum of 6 years’ experience in clinical research and strong therapeutic experiences in China. Understanding of all logistical aspects when conducting local, or regional/global clinical trials. Solid knowledge of GCP and relevant local regulations related to clinical research. Capable of providing TA, compound and protocol training in China as necessary. Strong knowledge on drug development, clinical research operations and regulatory requirements including GXP, ICH and local regulations or FDA CFRs (if applicable). Strong ability to synthesize and evaluate data generated from various reports and sources.

Excellent interpersonal skills and ability to demonstrate leadership. Internal and external partnering; ability to build relationships across the business internally and externally; ability to influence clinical research strategies to ensure successful execution of current and future clinical trials. Ability to identify opportunities for improvement and drive innovation in GCO organization. Experiences with people management role. Effective communication and leadership skills and ability to foster team productivity and cohesiveness. Experience mentoring/coaching others. Experience with people management is desirable. Ability to lead hiring, training, development and evaluation of people.

Proficiency in writing and speaking of English; Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint). Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner. 举报 分享

公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国***的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。

本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。

目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。

2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。