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- Partner with Drug Companies to Bring New Oncology Therapies to Market
- Improve Cancer Patient Outcomes through Early Diagnosis and Monitoring
About Our Client
- Advanced oncology focused IVD company
- The company develops blood tests for early detection in high-risk populations and monitoring in cancer survivors and provide advanced cancer patients with the information necessary to obtain the right treatment
On the commercial side, they also support drug companies to get new therapies to market faster through utilizing diagnostics in the clinical trial phase as a precise measure of efficacy
In Japan the company is still in growth phase, but have received large investment from major technology company to support in these efforts
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 clinical trial work experience in the pharmaceutical / CRO industry, ideally in the oncology space
- 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
- Contributed to a rapidly growing industry with potential to have huge impact on cancer patients' lives globally
Contact
Ed Marsden
Quote job ref
4219837
Phone number
+813 6832 8981
Job summary
Function
Specialisation
Industry
Location
Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
4219837
Company Type
