Johnson & Johnson Careers

【Janssen】 Japan R&D Regulatory Affairs, Labeling Staff

Chiyoda, Japan
Regulatory Compliance


Job Description

Requisition ID: 1905737656W

Janssen】 Japan R&D Regulatory Affairs, Labeling Staff
 
JOB SUMMARY:

Under the supervision of their supervisor:

・ Develop some Japanese package inserts (Japanese PI) based on Japanese target label

・ Run Japan Labeling committee process to develop labeling positions for marketed product issues

・ Participate in LWG for update of CCDS/USPI/ SmPC through inputting Japanese information and deliver updated information to J-Team

・ Maintain some Japanese PI in post-approval environment and negotiate Japanese labeling of Marketed products with HA

 
KEY RESPONSIBILITIES:

Under the supervision of their supervisor:

 Development J-PI

・ Participates in development of labeling negotiation Japanese strategies and development of supporting documentation for Japanese labeling

・ Develop Japanese PI from Japanese Target Label

・ Update Japanese PI based on updated CCDS and new data

・ Interface with tracking function to ensure that changes are being tracked and advise on Japanese label audit

・ Run the Japan Labeling Working Group process and participate in these groups

 Labeling Committee

・ Run Japan Labeling committee process to develop Japanese labeling positions for both development and marketed product issues

・ Explain labeling position on proposed labeling at the Japan Labeling Review Committee

・ Prepare final proposed Japanese PI for review by Labeling Working Group and Labeling Review Committee

 Relationship with Global Team

・ Serve as a support member of the global Labeling Working Group and provides input on proposed updates to the CCDS/USPI/SmPC

・ Receive information on CCDS/USOI/SmPC from Global Labeling and disseminate it to relevant people in JANSSEN JAPAN

・ Communicate with Global Labeling and/or CDT on creation/revision of Japanese PI

・ Share information with Global Labeling on US/EU/Japan labeling and act as a window to it

・ Provide support in preparing responses to Call for Information in preparation of PSURs regarding Japanese input (Approval information: Indication, Dosage and Administration etc).

 Post approval maintenance

・ Maintain Japanese PI in post-approval environment

・ Revise Japanese PI and provide input on implementation timelines as necessary

・ Provide labeling support necessary to defend the company labeling position in Japan when issues arise

・ Team with Japanese Labeling Therapeutic area representatives and collaborate with partners including Health Authorities, Manufacturing, Regulatory Operations, and Regulatory Affairs etc in Japan.

 Interactions with HA

・ Negotiate Japanese labeling of post-approval products with HA (ensure alignment with global strategy) as appropriate

・ Review Japanese PI in preparation for meeting with Health Authorities

 Print Labeling and others

・ Execute the technical aspects of labeling process (e.g., partner with Japan Submission Operations to prepare labeling submissions, and with Graphic Services to develop artwork for implementation in packaging and website display)

・ Prepare Japan unique explanatory documents called "Kaisetsusho" which explains rationale for "Precautions for Use" included in new drugs' J-PI.

・ Ensure effective quality control of labels



Qualifications
REQUIREMENTS:
Experience/Knowledge

・ A minimum of 3 years of pharmaceutical industry experience (clinical development, safety, regulatory affairs, medical affairs) and/or knowledge associated with product labeling/labeling regulations is required.

 
Skills/Capabilities

・ Good verbal and written communication skills in Japanese/ English is strongly preferred.

・ TOEIC score: over 700

 
Qualification/Certificate

・ A minimum of Bachelor’s degree in a scientific discipline, especially pharmaceutical science, is preferred.



Primary Location
Japan-Tokyo-To-Chiyoda-
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Regulatory Compliance
Requisition ID
1905737656W