EXPLORE

Careers at ThermoFisher Scientific

Apply Now >>    
Job ID :
63601BR
Location :
Japan - Tokyo
:
Job Description

Tasks

Clinical Duties

  • Design, implement and execute studies (clinical and analytical) within Japan for research and marketing purposes as well as to attain PMDA approval/clearance for innovative in-vitro diagnostics (IVD) and oncology. This includes authoring of clinical protocols and other study documentation such as CRFs, consent forms, monitoring plans, visit reports etc.
  • Develop/adopt policies and procedures for the conduct of clinical trials and drive improvements (in maintaining and tracking project plans, budgets and resources)
  • Select and negotiate contracts with cooperation partners
  • Coordinate and manage external service providers
  • Attend and present at investigational meetings
  • Organize and coordinate advisory board meetings
  • Establish and maintain KOL-networks in oncology
  • Identify KOLs, establish and maintain contact, manage cooperation including conference presentations and publications

Regulatory

  • Interact with PMDA in support of Japan registrations to negotiate Pre-approval studies, submissions, product intended use claims and claim extensions establishing requirements for clinical studies and their conduct
  • Review marketing materials designed for Japan distribution with regard to compliance with product claims/off -label use
  • Closely monitor changing PMDA policies and other regulatory bodies that have influence, and implement the respective steps.
  • Annual update of report and submission to PMDA

Others

  • Serves as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services.
  • Provides therapeutic area/indications training for project clinical teams
  • Profile

  • Doctor of medicine (MD)
  • English required
  • Excellent oral and written communication skills and ability to communicate to medical and business audience
  • At least 10 years of practical experience in all aspects of developing and executing clinical studies and biomarkers (IVD experience is a plus) in a company or CRO
  • High organizational skills and ability to work in a team environment
  • Capable of managing multiple projects simultaneously
  • Experience with the preparation of submissions
  • Specific knowledge of Japanese regulatory requirements (U.S. is a plus)

Entity: Life Technologies Japan



Apply Now >>    
Link for schema
Join our Talent Community

If you're ready to make a difference in the world, you can do it here.

Join

SHARE

5 Reasons to Work at Thermo Fisher Scientific
View
Search Jobs by Map
Search