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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




Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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