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Responsibilities

• Conduct Quality Control (QC) for clinical documents, including PMDA response documents, STED, PMDA consultation documents, protocols, and ICFs, following procedures.
• Ensure accuracy of clinical documents by comparing them to source documents.
• Understand and apply relevant SOPs and manuals for document quality control.
• Collaborate proactively on assigned projects, managing timing, scheduling, and tracking.
• Provide QC findings to document owners and relevant members to improve document preparation processes.
• Contribute to standardizing efficient processes for high-quality document development.
• Interpret and coordinate department-specific SOPs and work practices.
• Recommend alternative processes and approaches to solve problems.
• Foster teamwork and productivity.
• Manage SOPs and related documents, including the creation process for QMS documents.
• Lead and maintain the training matrix for all CMO functions in compliance with QR002.
• Collaborate with quality records managers on scheduling, tracking, and process improvements.
• Share key information from QRC to enhance efficiency and standardize processes.
• Register training packages in SUMMIT and assign participants.
• Manage CMO Lead activities.
• Manage J-EGC schedule and operations according to established procedures.
• Oversee research reviewed by J-EGC.
• Prepare and deliver regular J-EGC progress reports and updates.
• Maintain J-EGC SharePoint and management sheet.
• Maintain and update the research grant application website.
• Manage deliberation criteria for research grant eligibility, facilitate sessions, and prepare minutes.
• Notify physicians of research grant review results and manage contract procedures.
• Process research grant payments.
• Receive, evaluate, and track research reports.
• Manage the research grant budget.
• Lead discussions and execute solutions for issues based on consultations with HCC, Legal, Finance, and Medical Affairs.
• Register information in the MIRO system for MIR and manage the MIR process.
• Maintain the training process for sales representatives.
• Provide business support, including vendor management, contract handling, eMP applications, and cross-charge processes.
• Coordinate meetings, manage member lists, and maintain SharePoint for information management within CMO.

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

Location

• Chiyoda, Tokyo, Japan

About the Company

• At Johnson & Johnson, we believe health is everything.
• Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
• Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
• As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.
• We provide an inclusive work environment where each person is considered as an individual.
• At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.