[Innovative Medicine] Project Lead, Regulatory Medical Writing, Japan Document Management Group, IB Translation OfficePublication Owner Office
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Job Location:
Monthly Salary:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .
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 GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
ProfessionalAll Job Posting Locations:
Chiyoda Tokyo JapanJob 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&Js 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 Pay Grade:
- PG25 will start as an individual contributor focused on practical work with the aim of future promotion.
- PG26 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 Japans employee you are not able to apply for multiple positions at once.
- For Employee Referral Program (ERP) please read and understand the details of theInternal 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 PackagingRequired Experience:
Senior IC
Key Skills
- Floor Care
- Quality Assurance
- Hotel Experience
- Residential Cleaning
- Cleaning Experience
- Bus Driving
- Medical office experience
- Office Experience
- OSHA
- Heavy Lifting
- Custodial Experience
- Commercial Cleaning
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
