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MedDRA Sr Coordinator - (1712170) in Tokyo, JP at IQVIA™

Date Posted: 4/11/2018

Job Snapshot

Job Description

IQVIA™ is a leading integrated information and technology-enabled worldwide healthcare service provider. Formed by the merger of Quintiles and IQVIA™ , we use our experience, resources and reputation to help our clients drive healthcare forward.A career at IQVIA™ will give you the opportunity to play an important part in helping our clients improve patient healthcare and make real medical breakthroughs.
RESPONSIBILITIES  Oversee the execution of Start Up and/or Maintenance for assigned projects in accordance with the agreed RSU strategy. 
 Maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy. 
 Ensure collaboration across RSU, including communication with countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. 
 Assist with review of technical and administrative documentation to support business development and enable study initiation and maintenance, as required. 
 Support RSU Lead with initial start-up and maintenance phase activities as an integral member of the study management team. 
 Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; support execution of the RSU plan. 
 Assist with collection and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. 
 Ensure overall project efficiency and adherence to project timelines; report performance metrics as required. 
 Ensure appropriate quality standards (following RSU Management Plan and relevant Work Instructions) for the duration Start Up (or Maintenance, as applicable). 
 Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. 
 Assist in developing long standing relationships with preferred Quintiles customers. 
 Assist with presentations/training to clients, colleagues and professional bodies, as required.

Job Requirements

EEO Minorities/Females/Protected Veterans/Disabled

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 
 Good communication skills (written and oral) 
 Good interpersonal skills, a strong team player 
 Understanding of regulated clinical trial environment and knowledge of drug development process 
 Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines 
 Good leadership skills, with ability to motivate 
 Good organizational and planning skills 
 Understanding of study financial management 
 Good attention to detail 
 Ability to establish and maintain effective working relationships with co-workers, managers and sponsors. 

 MINIMUM REQUIRED EDUCATION AND EXPERIENCE 
Bachelor's degree in life sciences or related field, with 1 year’s relevant experience in a scientific or clinical environment or equivalent combination of education, training and experience. 
You can drive your career at IQVIA™ and choose the path that best defines your development and success. With exposure across diverse geographies, capabilities, and vast therapeutic and information and technology areas, you can seek opportunities to change and grow without boundaries.We invite you to join us on our exciting journey. Apply now.Help us make a difference in patient health.IQVIA™ is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential.

Job ID: 1712170