Senior Document Specialist - Document Publishing Solutions

About the role

Johnson & Johnson Innovative Medicine is recruiting a Senior Document Specialist for its Document Publishing Solutions (DPS) team 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 with authors and stakeholders to ensure submission-ready, compliant documents. The Japan team works closely with the Japan Medical Writing Group to advance digital transformation, including the use of AI.

Key responsibilities

• Provide technical quality control and submission-readiness support for regulatory documents such as clinical study reports, submission dossiers and protocols.
• Manage document publishing and document management activities in line with regulatory standards, internal procedures and submission requirements.
• Support the preparation of submission-ready documents through formatting, hyperlinking, bookmarking, document validation and publishing.
• Manage relationships with external service providers supporting publishing and document processing.
• Collaborate with the Japan Medical Writing Group and other stakeholders on regulatory submission documents.
• Evaluate, implement and support innovative technologies, including AI-enabled solutions, to improve efficiency and document quality.

Required profile

• Bachelor's degree (BS/BA) preferred.
• Required experience in document processing, publishing, information management, business systems or related operational support in the pharmaceutical, healthcare, technology or other regulated industries.
• Strong written and verbal communication in English (CEFR B2 or higher) and Japanese (native or CEFR C2 equivalent).
• Proven ability to manage vendor relationships and oversee outsourced publishing activities.
• Preferred: experience in people leadership, team management or mentoring.

Required skills

• Advanced Microsoft Word and Microsoft 365.
• Preferred: electronic document publishing, document management systems and pharmaceutical industry software such as Adobe Acrobat, ISI Toolbox, DocuBridge and Veeva Vault RIM.
• Preferred: structured authoring concepts, ICH M11 or similar regulatory document standards.

Domestic business trips may be required within the Tokyo metropolitan area; overseas travel is infrequent. Remote work up to two days per week is possible under company policy, and there is opportunity to collaborate with global DPS colleagues.