Medical Writer II

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 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.

 

 

Required Skills:

 

 

Preferred Skills:

Business Behavior, Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaboration, Copy Editing, Data Gathering and Analysis, Data Savvy, Document Management, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics