Manager Study Design
Responsible for Oversight of Clinical Operation Excellence
Contribute to Approval of Innovative New Medicines at Leading Pharma Company
- 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
- 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
- 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.
- Work in an international environment, clear career development opportunities, contribute to global clinical studies