Japan Project Physician || 臨床開発医師

Description: 
-Japan Project Physician (JPP) is accountable/responsible for the specific Japan expertise of the clinical strategy and program on the responsible products. 
i.e., accountable/responsible for
creation of study specification
creation of protocol
study implementation
interpretation of the results
provide contribution to Reg
Response preparation to clinical query
-JPP is a single point of contact on clinical projects


Key Responsibilities:
-Timely provision of Medical Scientific strategies for Japan clinical components of the Clinical Development Plan (CDP) of the Integrated Product Development Plan (iPDP) and Disease Area Strategy and Core labeling texts to the Global Product Teams (iMeds and GMeds) in AZ and Product Development Teams in MedI (PDT)
-Shared view with Clinical Scientists (CS) 
-Ensuring Japan project clinical strategies and plans receive peer review including external interactions to assure quality
-Timely input of scientific and medical perspectives into Japan commercial strategy including pricing & value strategy
-Ensure Japan publication plan is appropriate for the Japan medical environment and in alignment with the global publication strategy
-High level strategic external interactions in Japan, including Academic collaborations, Advisory Boards and Key Opinion Leaders
-Maintain and develop the medical and scientific knowledge with the area of expertise
-The JPP is responsible for the ethical integrity of Japan clinical plans and will deliver and own, according to agreed time, cost & quality, the medical scientific strategies for Japan clinical components of the CDP including the Design Specifications (DS) and study Specification (SS) to global Clinical Project Team (CPT) 
-Approval of Japan specific part (if applicable) of Investigator Brochure (IB)
-Implementation of Japan Clinical Study specific aspects of the patient risk management plan together with Patient Safety
-Provide medical input to post-marketing clinical studies required by the regulatory authorities and to develop DS/SS, approving Clinical Study Protocol (CSP) and Clinical Study Report (CSR) 
-Timely provision of Medical Scientific feasibility etc for Japan externalization projects
-Contribute to ensure the medical accuracy in the development of CSPs (incl. Master Informed Consent Form) and CSRs
-Contribute to and approve the medical content and aspects of Case Report Forms (CRF)s 
-Provide tactical medical input for operational matters during the conduct of the study eg advice to Clinical Research Associate (CRA)
-Manage the medical and safety issues surrounding the initiation, execution, and completion of a clinical study
-Set the extended reference range for clinical laboratory data in collaboration with MSD, if needed and review safety information including abnormal clinical laboratory data as a SDT physician
-Review the medical accuracy of IND documentation including preparation of response to Regulatory Authority 
-Be medically responsible for investigator meetings
-Japan Medical input to Japan Package Insert changes, PMS studies, Re-evaluation and regulatory queries on the Product 
-Contribute to identification of the expected safety risk factors that should be addressed in preparing the patient risk management plan, in cooperation with the global MSD
-Provide medical inputs to activities related to post-marketing surveillance plan and reexamination




Feeder roles:
-The person who meets the requirements above


Measures of Success:
-The context of clinical science input, including scientific risks, mitigations and setting right expectation of clinical development POS, is properly understood by the internal governance bodies for their quality decisions and by the internal stakeholders for the engagement.
-Optimum clinical science strategy is provided for optimum market access of the products within TA portfolio


Reporting Relationship / Team Membership:
-Report to TA Clinical Science Director, Clinical Science Division
-Direct reports: None

日本その他 地図

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