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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:
As a core responsibility, manage the daily progress of projects for translation office (Protocol, IB) and Publication Owner. Additionally, own the transformation of the IB translation process from the traditional outsourcing model to an efficient process that applies the latest technology, such as AI translation.
Key Responsibilities:
- Responsible for leading activities in the Translation Office and Publication Owner Office across all projects.
- Manages CRO throughout the project and gives instruction to FLEX staff for greater productivity.
- Perform proofreading after AI translation to ensure the draft quality meets PJ team review standards.
- Lead verification and operation of translation memory assets for the AI translation
- Be proactive in finding opportunities for greater efficiency and take the lead in finding and implementing flexible solutions.
- Can lead cross-functional or broader initiatives for process and business improvement.
- Strengthen team members and lead them to cultivate their development.
Qualifications
Education:
- A MS or other advanced degree with a minimum of 8 years of relevant pharmaceutical/scientific experience.
- A BS with a minimum of 10 years of relevant pharmaceutical/scientific experience.
Experience and Skills:
**Required: **
- A solid understanding of drug development is required.
- Strong project management skills are required. A PMP certification is highly desirable.
- Have interest and passion for groundbreaking technologies such as AI.
- Experience in working in cross-functional teams and supporting or leading large projects is required.
- Willing to build processes from a new point of view without being tied to existing processes.
- Understands J&J's CREDO based culture and has the willingness to grow while not only delivering results but also influencing those around them.
Preferred:
- Have experience in clinical trial result publication and an understanding of the related processes.
Other:
- Proficient Japanese speaking/writing skills.
- Proficient business English conversation skills.
- Sophisticated IT skills.
About Position:
- **Project Lead(Specialist) **will start as an individual contributor focused on practical work, with the aim of future promotion.
- **Project Lead(Senior)**will be developed as a management candidate, contributing to team education and leadership.
＜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