ãJanssenã R&D Japan Clinical Scientist (JCS) _IDV
ãJanssenã R&D Japan Clinical Scientist (JCS) _IDV
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Job Description
JOBSUMMARY:
JCS isresponsible to execute preparation for study implementation and clinical studyoversight of clinical studies in the assigned compound(s) and also executemedical monitoring of independent clinical study in Japan (Local study)including handling medical inquiries from JCOL the study operation team orinvestigators etc
KEYRESPONSIBILITIES:
Execute R&D publications based on the agreedR&D publication plan.
Supports to create revise and maintain study designand outlines scientific rationale Protocol Element Document (PED) and fullprotocol of the clinical studies aligned with the clinical study plan.
Provides leadership to implement study protocolincluding knowledge transfer to JCOL execution of clinical study oversight ofclinical studies in Japan in addition to supporting to create and update thefollowing documents:
-InvestigatorsBrochure (IB) Japanese translated version.
-Case ReportForm (CRF)
-FAQ onpatient eligibility or other medical issues and potential concerns duringexecution of clinical study in Japan.
-Summaryof the compensation system for subject health injury in Japan.
-Majorprotocol deviation criteria if any.
-Medicalmonitoring plan/medical review plan if any.
-StatisticalAnalysis Plan (SAP).
-Analyticalrisk based monitoring plan.
-Relatedother documents to clinical studies.
-Trainingmaterials for JCOL and study operation team involved.
Provides leadership to execute medical monitoringof the Local study including handling medical inquiries (secondary response)from JCOL the study operation team or investigators etc.
Provides leadership to execute risk and feasibilityassessment of full protocol of the studies including impact assessment ofunapproved in Japan out of scope in J-labelling imported drugs regardlessapproval in Japan.
Supports to create Clinical Study Report (CSR) ofthe Local study relevant parts of Common Technical Document (J-CTD) includingdiscussion on appropriate data interpretation from top line results andtabulations and key message clarification.
Supports to file CTD as JNDA including labelingdiscussion.
Supports to package insert (J-labelling)development.
Supports to develop risk management plan includingpost marketing surveillance studies led by JSS.
If post marketing clinical study in Japan isconsidered practical support will be necessary by JCS.
Provides own approaches from the viewpoints ofcareer and talent development.
JCS is assigned for each single clinical study asScientist role in the study. If JCS is additional assigned as Medical Monitorin the Local study the JCS needs to be trained by Study Responsible Physicianand/or Study Responsible Scientist before conduct of the study. Also if JCSbelow GB24 is considered practical support will be necessary by supervision ofJCL and/or Associate Director of the same group
- 3 yearsof pharmaceutical industry experience overall including clinical studyexperience at least 1 year
- Trainedoral and written communication skills in both English and Japanese.
- Goodplanning and tracking skills.
-Demonstrates influence negotiation and conflict resolution skills includingthe
ability toinfluence with supports from his/her supervisor.
-Demonstrates mind set of problem solving skills for developing creative
- M.S. orequivalent is required (M.D. Ph.D. preferable).
- English(TOEIC 750 or equivalent)
Employment Type
Full Time
