[Innovative Medicine] R&D, Medical Writer I , Medical Writing Group, Regulatory Medical Writing, Global Development

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:

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 a Medical Writer I (P4), located at J&J's Tokyo office.

Regulatory Medical Writing – Japan is part of the Integrated Data Analytics & Reporting (IDAR) business. 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 develop and submit create clear and efficiently produced documentation to Pharmaceuticals and Medical Devices Agency.

Key Responsibilities:

• Helps prepare sections of documents or write basic documents under close supervision such as, but not limited to, table of studies, Phase 1/2/3 CSRs, summary documents, and simple protocol amendments.

• May assist with document QC, completion of list of abbreviations and references, conduct literature searches, and other basic tasks.

• Learns and adheres to SOPs, templates, best practices, policies, and Medical Writing Style Guide.

• Regularly meets with manager and mentors and attends departmental meetings.

• Attends cross-functional meetings with other writers as appropriate (eg, project kick-off and review meetings).

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

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.

Preferred:

• Learns how to interpret, summarize, and present statistical and medical information.

• Solid oral and written communication skills.

• Attention to detail.

• Ability to function in a team environment.

• Organizes time well with short-term responsibilities.

• Demonstrates learning agility.

• Learns and applies knowledge of regulatory guidance documents such as ICH requirements.

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 more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

＜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.

 

 

Required Skills:

 

 

Preferred Skills:

Analytics Dashboards, Business Behavior, Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Copy Editing, Data Gathering Analysis, Data Savvy, Execution Focus, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Report Writing, Research Ethics