Description
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. Learn more at jnj.com.
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.
Job Function:
R&D OperationsJob Sub Function:
Clinical/Medical OperationsJob Category:
ProfessionalAll Job Posting Locations:
Chiyoda, Tokyo, JapanJob Description:
PURPOSE
Contribute to iMA's sustained performance and competitive advantage by improving quality and efficiency through systematic process improvement and standardization, including, but not limited to:
Process and external partnership management (SOPs, regulations, training, contracts, vendors, research grant management, purchase applications, seal applications, etc.)
Enhancing process compliance and ensuring the quality and accuracy of documentation through effective quality control practices.
Collaborate with internal and external stakeholders to support the development and implementation of clinically relevant policies, regulations and guidance.
MAIN REPONSIBILITIES / DUTIES
Key responsibilities include, but are not limited to:
n Quality Management System (QMS), SOPs, and Training
ü Lead and maintain the training matrix for iMA in compliance with QR002.
ü Manage SOPs and ensure full understanding and implementation of document quality control procedures.
ü Collaborate proactively with Quality Records Managers on scheduling, tracking, and continuous process improvement activities.
ü Share key information from QRC to enhance operational efficiency and promote process standardization.
ü Interpret and coordinate local-specific SOP requirements and recommend alternative approaches to resolve operational issues.
ü Foster teamwork, collaboration, and productivity across the organization.
ü Register training curricula in SUMMIT and assign learners as appropriate.
n Research Grants Office
ü Maintain and regularly update the research grant application website.
ü Manage research grant eligibility criteria, facilitate review committee meetings, and prepare meeting minutes.
ü Communicate review outcomes to research grant applicants and manage the associated contracting process.
ü Coordinate and process research grant payments.
ü Receive, evaluate, and track research reports.
ü Manage and track the research grant budget.
ü Lead discussions and implement solutions for operational issues in collaboration with HCC, Legal, Finance, and iMA stakeholders.
n MIR process
ü Enter and maintain information in the MIRO system and manage the MIR process.
ü Coordinate and maintain the training process for sales representatives.
ü Ensure compliance and process consistency related to MIR operations.
n Business support
ü Communicate with the iMA team and track the status of ongoing local studies.
ü Provide operational support for local evidence generation activities.
ü Provide essential support for business operations, including vendor management, contract administration, eMP applications, and cross-charge processes.
ü Support additional operational excellence initiatives for local evidence generation activities.
REPORTING STRUCTURE
This position reports to the manager, iMA Japan.
EDUCATION/ QUALIFICATIONS
Bachelor’s degree or equivalent is required.
SKILLS / COMPETENCIES
Experience in the healthcare industry is preferred. (Experience within pharmaceutical or medical device company is preferable.)
Experience in communicating with healthcare professionals is preferable.
Experience coordinating meetings and events is preferable.
Demonstrate ability to collaborate across functions to achive business objectives.
Proficiency in Microsoft Office and the ability to optimize administrative processes through digital tools.
Basic written English proficiency is required. Verbal communication skills in English are preferable.
Ability to work independently while collaborating effectively within cross-functional teams.
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