[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.