[Innovative Medicine] R&D, Medical Writer III, Japan Medical Writing, Regulatory Medical Writing, Gl

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 .

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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:
Medical Affairs Group

Job Sub Function:
Medical Writing

Job Category:
Professional

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for an Experienced Medical Writer, Medical Writer III (P6), located in Japan.

Our Medical Writing team prepares regulatory documents to deliver new medicines and expanded indications to patients as quickly as possible.

To achieve this, we work closely with our overseas colleagues to create clear and efficient documentation, contributing to the prevention of significant drug lag compared with other countries.
Key Responsibilities:


* Writes or coordinates clinical and regulatory documents such as, but not limited to, CSRs, protocols, summary documents, regulatory responses, and briefing documents.


* Leads cross-functional (eg, with clinical team) document planning and review meetings.

Interacts with cross-functional colleagues on document content and champions MW processes and best practices.

Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.


* Completes all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.


* Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision.

Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).


* Coaches or mentors more junior staff on document planning, processes, and content.

Provides peer review as needed.


* Actively participates in or leads process working groups.

Qualifications

Education:


* A university/college degree in a scientific discipline is required.

An advanced degree (eg, Masters, PhD, MD) is preferred.

Experience and Skills:

Required:


* At least 6 years of relevant pharmaceutical/scientific experience is required.


* At least 4 years of relevant clinical/regulatory medical writing experience is required.

Preferred:


* Recognizes how t...