[Innovative Medicine] Project Lead, Regulatory Medical Writing, Japan Document Management Group, IB Translation Office/Publication Owner Office

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.

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:

Position Summary:

This role will play a key role in the continued transformation of the Translation Office by leveraging AI translation, translation management technology, and data-driven process improvement. The Project Leader will contribute to advancing translation operations by identifying new opportunities, translating them into practical solutions, and leading their implementation in collaboration with cross-functional and global stakeholders.

We are looking for someone who combines strong project management capabilities with digital acumen and a continuous-improvement mindset. The successful candidate will be comfortable exploring emerging technologies, challenging established processes, collaborating across organizational boundaries, and turning innovative ideas into sustainable business improvements.

Key Responsibilities:

Play a key role in transforming translation processes for drug development and clinical study-related documents, identifying and implementing new ways to improve how translation work is performed.

Drive the optimization and further development of AI-enabled translation and translation management capabilities to improve translation quality, efficiency, consistency, and scalability.

Lead the effective utilization and enhancement of Translation Memory, terminology, feedback data, and other translation assets to continuously improve translation quality.

Develop and implement data-driven approaches to evaluate translation quality and process performance, identify improvement opportunities, and translate findings into actions.

Explore and implement opportunities to standardize, simplify, and automate translation and quality-control processes.

Participate in or lead cross-functional initiatives for digital transformation, process innovation, and business improvement.

Collaborate with global teams, technology partners, vendors, and business stakeholders to incorporate Japan requirements into translation technologies, workflows, and governance.

Drive adoption of new technologies and processes through effective stakeholder engagement, communication, and user support.

Coach and develop team members and external partners, building capabilities needed for the future Translation Office.

Qualifications

Education:

A university/college degree in a relevant discipline is required. An advanced degree is preferred.

At least 6 years of relevant pharmaceutical, scientific, technology, operations, or related professional experience is required.

Experience and Skills:

Required:

Commitment to J&J's Credo, achieving results, continuous growth, and positively influencing others.

Good understanding of drug development and clinical study-related documentation.

Strong project management skills, with experience supporting or leading cross-functional projects and initiatives.

Demonstrated ability to challenge existing ways of working, identify improvement opportunities, and contribute to practical solutions.

Strong analytical and problem-solving skills, with the ability to use data to drive decisions and improvements.

Strong digital acumen, with the ability to evaluate, adopt, and effectively apply emerging technologies, including AI, to business processes.

Strong collaboration and communication skills, with the ability to build productive relationships across functions and organizational boundaries.

Professional-level Japanese written and verbal communication skills.

Business-level English communication skills, with the ability to collaborate effectively with global stakeholders.

Preferred:

Experience in pharmaceutical or regulated document translation.

Experience with translation technologies such as AI/machine translation, Translation Management Systems, CAT tools, Translation Memory, or terminology management.

Experience in translation quality evaluation or process automation.

Experience managing vendors or external partners.

Experience in change management or implementation of new digital processes.

＜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