[Innovative Medicine] R&D, Senior Document Specialist, Document Publishing Solutions, Regulatory Med

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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.

...