[Innovative Medicine] Project Lead, Regulatory Medical Writing, Japan Document Management Group, IB

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 https://www.jnj.com

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:

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 https://www.jnj.com/.

Position Summary: 

The Project Lead in DMG, is responsible for taking leadership in IB Translation/Publication Owner Office activities for throughout all the projects.

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.

Additionally, establish efficient processes within the Publication Office.

Principal Responsibilities: 


* Responsible for the process/vendor management of IB translation office.


* Responsible for the process of preparation of materials for publication as Publication Owner.


* Works collaboratively in a team environment and makes recommendations across the projects with respect to timing, scheduling, tracking.


* Contributes to standardize the efficient process for high quality IB translation/Publication.

Be proactive in identifying opportunities for greater productivity and leads in finding and executing flexible solutions.

Can lead cross-functional or wider activities for process/business improvement.


* Manages CRO throughout the project and gives instruction to third party employee for greater productivity.
+ CRO oversight
+ Responsible for tasks/deliverables which ask to third party employee


* Strengthen team members and lead them to cultivate their development.

Education and Experience Requirements: 


* 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 and medical w...