Note: Applicants must have permission to work in Japan and Fluent ~ Native level Japanese
Compound life cycle management:
- Executes R&D KOL management.
- Execute R&D publications based on the agreed R&D publication plan.
Development planning and execution:
- Supports to create revise and maintain study design and outlines, scientific rationale, Protocol Element Document (PED) and full protocol of the clinical studies aligned with the clinical study plan.
- Provides leadership to implement study protocol including knowledge transfer to JCOL, execution of clinical study oversight of clinical studies in Japan, in addition to supporting to create and update the following documents:
- Investigator's Brochure (IB) - Japanese translated version.
- Case Report Form (CRF)
- FAQ on patient eligibility or other medical issues and potential concerns during execution of clinical study in Japan.
- Summary of the compensation system for subject health injury in Japan.
- Major protocol deviation criteria, if any.
- Medical monitoring plan/medical review plan, if any.
- Statistical Analysis Plan (SAP).
- Analytical risk based monitoring plan.
- Related other documents to clinical studies.
- Training materials for JCOL and study operation team involved.
- Provides leadership to execute medical monitoring of the Local study, including handling medical inquiries (secondary response) from JCOL, the study operation team or investigators, etc.
- Provides leadership to execute risk and feasibility assessment of full protocol of the studies including impact assessment of unapproved in Japan, out of scope in J-labelling, imported drugs regardless approval in Japan.
- Supports to create Clinical Study Report (CSR) of the Local study, relevant parts of Common Technical Document (J-CTD), including discussion on appropriate data interpretation from top line results and tabulations, and key message clarification.
- Supports to file CTD as JNDA including labeling discussion.
Post marketing activities:
- Supports to package insert (J-labelling) development.
- Supports to develop risk management plan including post marketing surveillance studies led by JSS.
- If post marketing clinical study in Japan is considered, practical support will be necessary.
- BS degree
- Pharmaceutical experience
- Experience in clinical development
- Ability to communicate in English