JCS is responsible to execute preparation for study implementation and clinical study oversight of clinical studies in the assigned compound(s) and also execute medical monitoring of independent clinical study in Japan (Local study), including handling medical inquiries from JCOL, the study operation team or investigators, etc
Execute R&D publications based on the agreed R&D publication plan.
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.
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 by JCS.
Provides own approaches from the viewpoints of career and talent development.
JCS is assigned for each single clinical study as Scientist role in the study. If JCS is additional assigned as Medical Monitor in the Local study, the JCS needs to be trained by Study Responsible Physician and/or Study Responsible Scientist before conduct of the study. Also, if JCS below GB24 is considered, practical support will be necessary by supervision of JCL and/or Associate Director of the same group
- 3 years of pharmaceutical industry experience overall including clinical study experience at least 1 year
- Trained oral and written communication skills in both English and Japanese.
- Good planning and tracking skills.
- Demonstrates influence, negotiation and conflict resolution skills, including the
ability to influence with supports from his/her supervisor.
- Demonstrates mind set of problem solving skills for developing creative
- M.S. or equivalent is required (M.D., Ph.D. – preferable).
- English (TOEIC 750 or equivalent)
Janssen Pharmaceutical K.K. (7195)