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About the Role

Leads operational management of a Case Management Group, implementing operational plans and ensuring efficient, compliant, high-quality, timely case management operations while optimizing resource utilization and operational throughput. Communicates and builds effective relationships with relevant stakeholders to provide vision, strategic direction, and alignments in case management.

Responsibilities

• Ensure the quality of outputs related to case processing activities and maintain compliance with applicable timelines.
• Control the quality of outputs provided to PMDA, Global Medical Safety (GMS), Local Medical Safety (LMS), and other groups for safety-related activities.
• Lead implementation plans in case management and improvement with a risk-based approach.
• Control compliance with timelines for PMDA reporting and headquarters reporting.
• Escalate compliance risks with potential countermeasures to supervisors and stakeholders.
• Monitor the quality and compliance of the adverse event (AE) reporting process.
• Plan and take appropriate countermeasures with alignment in stakeholders as needed.
• Establish more efficient and reliable case processing in accordance with business requirements, including the utilization of outsourcing where appropriate.
• Evaluate the impact of new SOPs and related regulations, and implement new or revised processes.
• Handle internal audits and external inspections related to case processing such as investigation, proposing corrective/preventive action, alignment with stakeholders and escalation to supervisor.
• Build and maintain effective communication with LMS Japan personnel and other relevant stakeholders.
• Provide advice and align with stakeholders as SME.
• Identify resource demands and visualize appropriate resources allocation for ICSR operation within the group.
• Propose appropriate assignment of case processing tasks to staff and monitor the status and progress of those tasks.
• Provide appropriate On-the-Job (technical) training and guidance to staff, and coach and train junior colleagues.
• Escalate operational risks to supervisor, if necessary.

Requirements

• Minimum of 6 years of pharmaceutical industry experience.
• Experience working in a cross-cultural and/or global environment is required.
• Extensive knowledge of and experience with safety reporting and regulatory compliance, including experience with international safety reporting requirements and regulations.
• Sound knowledge of general medicine, pharmacy, or clinical practice, with proficiency in medical terminology (local language).
• Strong leadership skills and the ability to lead a team.
• Ability to negotiate and communicate effectively with internal and external customers.
• Ability to plan allocation of case assessment resources.
• Ability to evaluate processes and procedures against outcomes and identify opportunities to improve efficiency, accuracy, and compliance.
• Ability to prioritize work and operate effectively under strict timelines on a daily basis.
• Demonstrates strong Credo values.
• Strong English communication skills (TOEIC 800 or above preferred), including verbal, written, presentation, and facilitation skills.
• Good computer skills (Word, Email, Excel, PowerPoint) and familiarity with safety systems.

Skills

• Cross-Functional Collaboration
• Developing Others
• Global Market
• Inclusive Leadership
• Leadership
• Medicines and Device Development and Regulation
• Operations Management
• Performance Measurement
• Pharmacovigilance
• Quality Control (QC)
• Quality Management Systems (QMS)
• Regulatory Affairs Management
• Report Writing
• Safety Investigations
• Safety-Oriented
• Safety Reporting
• Serious Adverse Event Reporting
• Team Management

Location

• Chiyoda, Tokyo, Japan

Work Type

• Full-time

Experience Level

• 6+ years

Education Level

• Bachelor's degree or equivalent education in Health Sciences or another directly related field, or an equivalent combination of education, training, and experience.

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.