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**Job Function: **
Medical Affairs Group
**Job Sub Function: **
Medical Writing
Job Category:
People Leader
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description:
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 for direct reports.
- Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing feedback on performance and development.
- Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
- Ensures direct report’s 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-year performance reviews, 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 Japan’s 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.
**Required Skills: **
Preferred Skills:
Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Copy Editing, Cross-Functional Collaboration, Developing Others, Inclusive Leadership, Industry Analysis, Leadership, Medical Affairs, Medical Communications, Performance Measurement, Quality Validation, Standard Operating Procedure (SOP), Succession Planning, Tactical Planning