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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 to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision.
• Excellent oral and written communication skills.
• Attention to detail.
• Ability to function in a team environment.
• Organizes time well.
• Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves complex problems under supervision.
• Demonstrates learning agility.
• Builds solid and productive relationships with cross-functional team members.

Other:

• Fluent Japanese, intermediate or higher English skill is requirement.
• Domestic business trips are sometimes limited to the Tokyo metropolitan area, and overseas travel is infrequent.

＜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.

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Preferred Skills: