Manager Study Design

Japan Permanent Foreign Multinational
  • Responsible for Oversight of Clinical Operation Excellence
  • Contribute to Approval of Innovative New Medicines at Leading Pharma Company

About Our Client

  • Industry leading US biopharmaceutical company, with expertise in oncology, immunology, infectious disease, cardiovascular disease areas
  • Over 10 Bn USD investment in recent R&D pipeline

Job Description

  • Policy and protocol planning for post-marketing surveillance
  • Develop research policy and plan, and estimate research budget for assigned drugs and indications based on agreement with relevant parties to obtain global approval
  • GAP analysis and evidence generation (non-regulatory)
  • Actively participate in GAP analysis and research planning as a partner of TA in the assigned disease area
  • Publication to be responsible for the preparation and publication of the manuscript as an author in the assigned project.
  • Comply with industry and company rules and ensure that all employees are aware of them (including education)
  • Propose the most effective solution to inquiries from PMDA regarding post-marketing surveillance for which you are in charge, and negotiate with PMDA through internal agreement
  • Negotiate with PMDA through internal agreement.
  • Share and communicate information appropriately with all internal stakeholders related to the project to ensure that the study in charge proceeds as planned

The Successful Applicant

  • Over 5 years of work experience in the pharmaceutical industry
  • Work experience related to quality control or quality assurance
  • Related to new drug approval (GCP compliance survey) or reexamination compliance survey (GPSP compliance survey)
  • Problem-solving skills
  • Assertive communication
  • Knowledge of related regulations (ICH-GCP, J-GCP, GPSP, etc.)
  • TOEIC 700 points or more (English document preparation, meetings, email correspondence available)
  • Have the ability to properly identify the gap between the current state of the organization and what it should be, and deal with that gap.

What's on Offer

  • Work in an international environment, clear career development opportunities, contribute to global clinical studies
Ed Marsden
Quote job ref
Phone number
+813 6832 8981

Job summary

Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
Company Type