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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Senior Document Specialist, Document Publishing Solutions (DPS), located in the Tokyo office, Japan.

DPS is a global team that delivers document publishing, technical quality control, and document management services for regulatory submission documents. Working in partnership with authors and stakeholders, DPS ensures submission-ready, compliant, and high-quality documents that support successful regulatory submissions worldwide. The DPS Japan team works closely with the Japan Medical Writing Group to advance digital transformation initiatives by introducing innovative technologies, providing technical expertise, and promoting the practical application of AI to enhance day-to-day operations.

Key Responsibilities:

• Provide technical quality control (QC) and submission-readiness support for regulatory documents (e.g., clinical study reports, submission dossiers, protocols, and related deliverables)

• Manage document publishing and document management activities, ensuring compliance with regulatory standards, internal procedures, and submission requirements.

• Support the preparation of submission-ready documents through formatting, hyperlinking, bookmarking, document validation, and publishing activities.

• Manage relationships with external service providers supporting publishing and document processing activities to ensure quality, efficiency, and timely delivery.

• Collaborate closely with the Japan Medical Writing Group and other cross-functional stakeholders to deliver high-quality regulatory submission documents.

• Drive digital transformation initiatives by evaluating, implementing, and supporting innovative technologies, including AI-enabled solutions, to improve operational efficiency, enhance document quality, and promote knowledge sharing across the organization.

Qualifications

Education:

• Bachelor's degree (BS/BA) is preferred.

Experience and Skills:

Required:

• Experience in document processing, publishing, information management, business systems, or related operational support activities within the pharmaceutical, healthcare, technology, or other regulated industries.

• Strong written and verbal communication skills in both English (CEFR B2 or higher) and Japanese (native proficiency or CEFR C2 equivalent).

• Strong digital literacy, including advanced proficiency in Microsoft Word and other Microsoft 365 applications.

• Proven ability to manage vendor relationships and oversee outsourced publishing activities.

Preferred:

• Demonstrated experience in people leadership, team management, or mentoring others.

• Demonstrated proficiency in electronic document publishing, document management systems, and other pharmaceutical industry-standard software (e.g., Adobe Acrobat, ISI Toolbox, DocuBridge, Veeva Vault RIM).

• Demonstrated interest in emerging technologies, automation, and AI applications within regulated environments.

• Solid understanding of structured authoring concepts, ICH M11, or related regulatory document standards.

Other remarks:

• Domestic business trips may be required, primarily within the Tokyo metropolitan area; overseas travel is infrequent.

• Employees may work remotely up to two days per week in accordance with company policy.

• Opportunity to collaborate with global DPS colleagues and cross-functional stakeholders supporting regulatory submissions worldwide.

＜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:

Coaching, Communication, Competitive Landscape Analysis, Compliance Management, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Product Packaging Design, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Researching, Safety-Oriented, Sustainability, Sustainable Packaging