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About the Role

Johnson & Johnson Innovative Medicine is seeking a Senior Document Specialist for the Document Publishing Solutions (DPS) team in Tokyo, Japan. This role provides technical quality control and submission-readiness support for regulatory documents, manages document publishing and management activities, and drives digital transformation initiatives using innovative technologies like AI.

Responsibilities

Provide technical quality control (QC) and submission-readiness support for regulatory documents.
Manage document publishing and document management activities, ensuring compliance with regulatory standards and internal procedures.
Support the preparation of submission-ready documents through formatting, hyperlinking, bookmarking, validation, and publishing.
Manage relationships with external service providers supporting publishing and document processing.
Collaborate with the Japan Medical Writing Group and other stakeholders to deliver high-quality regulatory submission documents.
Drive digital transformation initiatives by evaluating and implementing innovative technologies, including AI-enabled solutions.

Requirements

Bachelor's degree (BS/BA) preferred.
Experience in document processing, publishing, information management, business systems, or related operational support within the pharmaceutical, healthcare, technology, or other regulated industries.
Strong written and verbal communication skills in 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.
Demonstrated experience in people leadership, team management, or mentoring others (preferred).
Demonstrated proficiency in electronic document publishing, document management systems, and pharmaceutical industry-standard software (e.g., Adobe Acrobat, ISI Toolbox, DocuBridge, Veeva Vault RIM) (preferred).
Demonstrated interest in emerging technologies, automation, and AI applications within regulated environments (preferred).
Solid understanding of structured authoring concepts, ICH M11, or related regulatory document standards (preferred).

Skills

Document Processing
Document Publishing
Information Management
Business Systems
Operational Support
Microsoft Word
Microsoft 365
Vendor Relationship Management
Electronic Document Publishing
Document Management Systems
Adobe Acrobat
ISI Toolbox
DocuBridge
Veeva Vault RIM
Emerging Technologies
Automation
AI Applications
Structured Authoring
ICH M11
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

Location

Chiyoda, Tokyo, Japan

Work Type

Remote up to two days per week
Domestic business trips may be required
Overseas travel is infrequent

Experience Level

Senior

Education Level

Bachelor's degree (BS/BA) preferred

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.
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.