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Job Description:

Johnson & Johnson Innovative Medicine is recruiting for an Experienced Medical Writer, Medical Writer II (P5), 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, contributes to, and/or coordinates low to medium complexity clinical and regulatory documents such as, but not limited to, Phase 1/2/3 CSRs and protocols, summary documents, and regulatory responses under supervision.
• Performs document QC, completes list of abbreviations or references, conducts literature searches, and performs other basic tasks with supervision as needed.
• Participates in and may lead cross-functional document planning and review meetings. Works in a team environment with some guidance while increasing independence for longer-term activities.
• Takes an active role on assigned projects with respect to timing, scheduling, and tracking.
• 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.
• In accordance with experience levell: —guides or trains cross-functional team members on processes and best practices. -- leads early- or late-stage compound writing teams with supervision, as required.

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:

• A minimum of 2 years of relevant pharmaceutical/scientific experience is required.
• A range of 0 to 4+ years of regulatory medical writing experience is required, depending on tasks performed and level of supervision needed.

Preferred:

• Strong oral and written communication skills.
• Attention to detail.
• Ability to function in a team environment.
• Organizes time well.
• Demonstrates learning agility.
• Builds solid and productive relationships with cross-functional team members.
• Gains experience in interpreting, summarizing, and presenting statistical and medical information to ensure quality and accuracy of content with supervision.
• Emerging leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves basic problems independently and more complex problems with supervision.
• Develops and applies knowledge of regulatory guidance documents such as ICH requirement

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.

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