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**Job Function: **
R&D Operations
**Job Sub Function: **
Clinical/Medical Operations
Job Category:
Professional
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description:
MAIN REPONSIBILITIES / DUTIES
Main responsibilities will include, but are not limited to:
- Quality Controll of official documents
This position is responsible for conducting Quality Control (QC) for clinical documents related to PMDA response documents including but not limited to PMDA inquiries, STED and any other PMDA consultation documents, according to procedure. As appropriate, clinical trial documents such as protocol/ICF etc. are included.
Conduct QC of clinical documents based on QR083
Ensure the accuracy of clinical documents comparing to the source documents.
Fully understand SOPs and manuals related document quality control.
Work collaboratively in a team environment and take proactive role on assigned project with respect to timing, scheduling, tracking as appropriate.
Provide important information obtained from QC activities to the document owner and other relevant members in order to improve the process of document preparation.
Contribute to standardize the efficient process for high quality document development.
Recognize how to best interpret and coordinate the department specific standard operating procedures and work practices. Be able to leverage experiences to recommend alternative processes and approaches to solve problems.
Interact in a manner that facilitates teamwork and productivity. Take an active role on assigned programs.
Management of QMS related activities, SOPs, and Training
This position is responsible for managing SOP and documents related to SOPs, and creation process of each QMS related documents are included.
Lead and maintain the training matrix for all CMO functions in compliance with QR002.
Manage SOPs and ensure full understanding of document quality control procedures.
Collaborate proactively with quality records managers on scheduling, tracking, and process improvements.
Share key information from QRC to enhance efficiency and standardize processes.
Interpret and coordinate department-specific SOPs; recommend alternative approaches to solve problems.
Foster teamwork and productivity.
Register training packages in SUMMIT and assign participants.
Management of CMO Lead activities.
J-EGC Office
Responsibilities:
- Manage J-EGC schedule
- Operate J-EGC in accordance with established J-EGC procedures.
- Oversee research reviewed by J-EGC.
- Prepare and deliver regular progress reports and updates.
- Maintain J-EGC sharepoint and J-EGC management sheet.
Research Grants Office
Responsibilities:
- Maintain and perform regular updates on the research grant application website.
- Manage deliberation criteria for research grant eligibility, facilitate deliberation sessions, and prepare meeting minutes.
- Notify physicians who applied for research grants of the review results and manage contract procedures.
- Process payment of research grants.
- Receive, evaluate, and track research reports.
- Manage the research grant budget
- Lead the discussion and execution of solutions to issues based on consultations with HCC, Legal, Finance, and Medical Affairs.
MIR process
Responsibilities:
Register information in the MIRO system for MIR, and manage MIR process.
Maintain the training process for sales representatives.
Business support
Provide essential support for business operations, including vendor management, contract handling, eMP applications, and cross-charge processes.
Coordinate meetings, manage member lists, and maintain SharePoint for information management within CMO.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Analytics Insights, Coaching, Collaboration, Data Analysis, Data Savvy, Detail-Oriented, Digital Culture, Digital Literacy, Healthcare Trends, Medical Affairs, Medical Communications, Medical Compliance, Process Oriented, Product Development Lifecycle, Scientific Research, Technical Writing, Technologically Savvy