[Janssen] Clinical Research Lead - fixed term

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

1. 포지션: Sr. MAF Research Excellence Specialist

2. 계열사: 한국얀센 (Janssen) 

3. 근무지: 서울시 용산구

4. 근무 형태: Fixed Term

[Summary] 
The Research Excellence Specialist is responsible for overall management of research process and documentation in Company sponsored studies(CSS) of Medical Affairs(MAF) and takes a role as a local representative for AP-initiated evidence generation project and dissemination process.

[Responsibilities] 
1. Manage overall study process in company sponsored studies(CSS) of Medical Affairs(MAF), aligned with MAF TA(Therapeutic Area) and Medical Affairs Operation(MAO)
-    Manage the overall timeline, budget and resource using a proper tool to enable study team to achieve key milestones in a timely and compliant manner
-    Communicate with MAO as MAF representative in CSS to discuss the study status and issue management 
-    Coordinate study related system and process such as Medical executive committee(MEC), Research concept approval process(ReCAP), AP protocol review committee(PRC), and Janssen Publications Management System(JPUBS), and train study team where needed

2. Review the study documents to check the integrity of study material and generate if necessary
-    Review the synopsis/protocol/clinical study report in the aspects of Good Clinical Practice(GCP), Standard Operating Procedure(SOP), international guidelines such as ICH as well as relevant local regulations 
-    Act as SME to support MAO by generating documents according to MFDS’s request

3. Lead projects initiated by the region/global team related to studies to enhance the process of data generation/dissemination to bring the maximized impact of studies

• Act as a local champion in Integrated evidence generation planning(IEGP)/Integrated evidence dissemination planning(IEDP) process by participating the AP regular meeting and leading the local process 
• Share best practice with organization and encourage them to implement the best approach

[Requirements]

• About 5 years experiences in clinical research, medical writing and statistics are preferred

• BS is required and advanced degree in MA/MS/MBA in pharmacy, nursing, or public health is preferred

• Experience in professional working environment in the pharmaceutical or related industries is preferred

• Understanding of local regulations and industry’s code of practice related to drug registration, pharmaceutical promotion and clinical study including PMS

• Sound knowledge of the key J&J products

• Achieves personal goals with energy and enthusiasm; sets challenging goals for self and overcomes most obstacles

• Understanding of ICH-GCP, KGCP, and local regulation

• Comprehensive understanding of relevant company policy and/or SOP

• Good verbal and written communication skills

[지원 방법] 
www.careers.jnj.com 접속 -> Position Number 2306105615W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행 

[제출 서류]
영문 자유 양식의 이력서/자기소개서 

[서류 마감일] 
채용시 마감

[For more Johnson & Johnson]

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• J&J Linkedin: https://www.linkedin.com/company/johnson-&-johnson/

• J&J Corporate Page: http://www.jobkorea.co.kr/Company/1605233/Info

[유의사항] 

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