- Responsible for Oversight of R&D Quality and Compliance
- Contribute to Approval of Innovative New Medicines for Growing Biopharma Company
- World renowned Medical Device company with specialism in Orthopaedics, Diabetes, Cardiovascular
Collaborate closely with RA, clinical development and overseas clinical trial team within the Japanese corporation, coordinate and lead these, and carry out the following tasks:
- Sharing of information related to conformity surveys
- Responding to Japanese reliability standards and concerns about GCP
- Collection of overseas clinical trial data
- Collect documents and records relating to the criteria for conducting clinical trials of medical devices, created and stored by the sponsor and those created by implementing medical institution and provided to the sponsor
- Prepare so that it can be verified that overseas clinical trial materials are prepared or stored in accordance with the reliability standards of application materials.
- Where necessary, eliminate incomplete materials and discrepancies between materials
- Respond to conformity assessment by PMDA Reliability Assurance Division (PMDA)
- Act as contact point for PMDA, respond and negotiate
- Conduct an initial interview with PMDA if there is concern about meeting the standards in Japan
- Preparation for conformity survey (written / GCP field)
- Collaboration with overseas clinical trial teams
- Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional
years of equivalent experience will be considered.
- Good quality mindset and apittude for process improvement
- Experience with effectively managing regulatory agency inspection and working with
regulators and internal staff to help prepare for inspections is required.
- An understanding of drug / device regulations, development processes and HA
inspection procedures is required.
- English and Japanese fluency is required.
- Experience developing SOPs, reviewing internal clinical, pharmacovigilance,
regulatory and medical processes to ensure they are accurately represented in current
SOPs is essential.
- Ability to organize and conduct internal audits is necessary.
- Ability to conduct external audits on Investigator Sites, CROs, supporting laboratories,
and monitoring organizations with responsibility for writing audit reports as well as
reviewing and tracking QEs/CAPAs.
- Work in an international environment, clear career development opportunities, contribute to global clinical studies
- Work as part of Global R&D organization
- Contribute to approvals of new drugs in rare disease areas