This position is accountable for all scientific discussion/deliverables, especially in case of the necessity of some clinical data, study design and outlines, study results and clinical data package in clinical studies (included company initiated studies (CIS) and Post Marketing Surveillance (PMS)) in the assigned projects, from early to post-marketing. This position is responsible to discuss the clinical data package and/or the necessity of clinical data, to execute designing, implementation and completion of clinical studies fulfilling clinical data package for appropriate submission and also to execute appropriate communication with Pharmaceuticals and Medical Devices Agency (PMDA) about clinical studies; e.g. PMDA consultation, submission, etc
And accountable to ensure input and support in the development of Evidence Generation strategy as representative from Clinical Research.
- Responsible for team’s interface and collaboration with Key Opinion Leaders(KOLs) and management.
- Lead clinical scientific discussions with PMDA, including proposed clinical investigations.
- Lead the confirmation for clinical data, study results, and essential documents for the clinical data package, and lead the regulatory inspection by PMDA
- Develop, revise and maintain study design and outlines, scientific rationale, Protocol Synopsis and full protocol of the local clinical studies/CIS/PMS.
- Lead to implement study protocol including knowledge transfer to clinical operation team, execution of clinical study oversight of clinical studies/CIS/PMS in Japan, and also to prepare for the following documents as applicable: Investigator’s Brochure (IB) – Japanese translated version
FAQ on patient eligibility or other medical issues and potential concerns
Related other documents to clinical studies
Training materials for clinical operation team involved and investigators
- Lead to execute medical monitoring while conducting independent clinical study in Japan (Local study).
- Lead to develop Clinical Study Report (CSR) of the Local study, relevant parts of Summary of Technical Documents (STED), including discussion on appropriate data interpretation from top line results and tabulations, and key message clarification.
- Lead to develop annual report of PMS and report to Health Authority
- Lead to develop publication plan with collaborative relationships with Medical Affairs.
- Lead to file relevant parts of STED as JNDA including labeling discussion.
- Contribute to package insert (J-labelling) development.
- Develop and maintain working relationships with others requiring interaction and mutual support
- Contribute the development and deliver appropriate Evidence Generation strategy to support New Product Development and Life Cycle management with collaborative relationships with all cross-functional partners (e.g. Marketing, Medical Affairs, Regulatory Affairs. HEMA, etc).
・日本語（reading、writing、speaking、Native Speaker level）
Johnson & Johnson K.K. (8235)