[Innovative Medicine] R&D, Director, Japan Medical Writing, Regulatory Medical Writing, Global Development

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Position Summary:

The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing knowledge and expertise in RegMW strategic concepts and processes.

This role is accountable for the strategic and operational leadership of Reg MW activities for Japan and China.

The role is a primary liaison with cross-functional teams driving strategic discussions developing internal medical writers and ensuring adherence to best practices and regulatory guidelines. The Director RegMW has the authority to oversee projects identify risks and implement process improvements while managing internal medical writing teams and contributing to organizational initiatives. The Director will influence strategies lead process working groups champion internal standards and improve internal systems and tools. The role requires strong partnership and close collaboration with senior functional and matrix leaders across Innovative Medicine R&D (IMRD) organization in Japan and China to ensure the successful efficient high-quality and compliant portfolio delivery.

Principal Responsibilities:

• Overall accountability for decision-making within the Japan & China medical writing organization ensuring alignment with strategic goals.

• Proactively identify potential risks and develop mitigation strategies enhancing project outcomes and minimizing obstacles.

• Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables working independently to find effective solutions.

• Represent the MW department with decision-making authority in the R&D organization leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments.

• Serve as a liaison between team members and senior leadership within a Therapeutic Area (TA) or sub-function facilitating effective communication and collaboration.

• Develop implement and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners championing these initiatives to cross-functional team members.

• Mentor support and coach staff at all levels on document planning processes and content providing peer review as needed.

• Maintain and disseminate knowledge of industry company and regulatory guidelines within relevant company systems.

• Participate in industry working groups to represent MW and ensure alignment with best practices.

• Accountable for setting the strategy and operational execution for portfolio(s) within the Japan and China RegMW team in close consultation and accordance with the Delivery Unit (DU) Head and in line with R&D priorities and TA objectives. Accountable for MW resource management and allocation within their portfolio(s).

• Can represent MW department at high-level and cross-functional TA meetings and has significant independent decision-making authority.

• Provides leadership to writing teams by helping attract and retain top talent developing team members and ensuring organizational effectiveness transparency and communication. Responsible for creating an environment where employees feel engaged and empowered and take pride in their role responsibilities and deliverables.

• Takes on additional major responsibility with minimal supervision operating at an expert level with accountability for the highest levels of quality:

• Cross-functional cross-TA cross-J&J initiative/collaboration.

• As a people manager:

• Supervises/manages and is accountable fordirect reports.

• Sets objectives and agrees on goals for direct performance oversight including providing feedback on performanceanddevelopment.

• Regularly meets with direct reports to ensure appropriate development projects assignments and issues are resolved.

• Ensures direct reports adherence to established policies procedural documents and templates.

• Participates in hiring staff onboarding new staff conducting career and talent development discussions goal-setting end-of-yearperformancereviews and compensation planning.

Principal Relationships:

• Functional contacts within Johnson & Johnson Innovative Medicine (as collaborator and peer).

• Internal: Regulatory MW leadership teams manager peer writers employees from other departments such as Matrix Leaders from Therapeutic and Functional Areas including Clinical (TA Heads) Global Development Delivery Units Integrated Data Analytics and Reporting Statistics Data Sciences R&D Quality Project Management Global Clinical Operations Medical Affairs Operations Global Medical Safety Global Regulatory Affairs and Operations IT Procurement Partnerships and Cross-sector counterparts.

• External: May oversee day-to-day project-related work of contractors or external service providers as needed. May collaborate with external partner company staff on codeveloped compounds. Interacts with experts cross-pharma cross-sector and with business partners from other companies.

• Supervision: Direct or dotted line reports and others as assigned.

Education and Experience Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (eg Masters PhD MD) is preferred.

• At least 14 years of relevant pharmaceutical/scientific experience is required.

• At least 12 years of relevant clinical/medical writing experience is required.

• If a people manager: at least 5 years of people management experience is required.

• Expertise in project management and process improvement is required.

• Strong decision-making skills strategic thinking agility broad vision is required.

Other:

• Business Proficiency in English is required.

• Attention to detail.

• Expert time management for self direct reports (if applicable) and teams.

• Ability to delegate responsibility appropriately.

• Expert ability to lead and influence by example and stay focused (positive). Demonstrate integrity.

• Expert ability to motivate and develop best in class talent pipeline.

• Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers.

• Creates a positive Credo-based work environment for staff members.

• Shows openness to new ideas and fosters organizational learning.

For Internal Applicants

• Based on your experience and interview evaluation the position title and level may vary.

• If you are Japan employee please read Internal Application Guideline in Ask GS. Especially if you are less than 18 months in your current role you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japans employee you are not able to apply for multiple positions at once.

• For Employee Referral Program (ERP) please read and understand the details of the Internal Referral Overview on the Ask GS and you have made a compliant referral.

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