[Innovative Medicine] R&D, Medical Writer I , Medical Writing Group, Regulatory Medical Writing, Global Development
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Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Medical Affairs GroupJob Sub Function:
Medical WritingJob Category:
ProfessionalAll Job Posting Locations:
Chiyoda Tokyo JapanJob Description:
Johnson & Johnson Innovative Medicine is recruiting for a Medical Writer I (P4) located at J&Js 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 .
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 Japans employee you are not able to apply for multiple positions at once.
For Employee Referral Program (ERP) please read and understand the details of theInternal 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 EthicsRequired Experience:
Exec
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
