Japanese Labelling & Artwork Manager

Job Number: 1450

External Description:

Primary Purpose:
Provides Japanese Labelling & Artwork Regulatory expertise across a Therapeutic business unit.  Delivers strategic and operational regulatory input and guidance to the cross functional teams.

MAJOR RESPONSIBILITIES 
•    Creation, update and maintenance of the Japanese package inserts in line with the CCDS, Agency RTQ, and most up-to-date labelling requirements and labelling template required in Japan and according to SOPs

•    If applicable, for assigned Early development assets, deliver competitive labelling searches and contributes to the TCLP for Japan (collaborating with Global Labeling Lead: GLL)

•    Key point of contact for the Japanease Package Insert (digital package insert, Module 1.8) for internal (GRA + strategic Partners in Japan) and external stakeholders (clinical, medical, legal, commercial, safety, quality and be the Japan labeling representative in team meetings (DTJ, Global RST, LET, Japan Submission Team, …).  Lead Reviews, Round Tables, Approvals for the Japan Labeling in the appropriate system and according to SOP

•    Delivers operational excellence for all labelling activities according to timelines, such as appropriate tracking of the Japan labeling in the appropriate system and according to SOP
•    Linguistic review process for ensure labelling compliance: Lead with local regulatory lead the Linguistic review according to Green book, assist with the preparation of the Closing Sequence and ensure communication of HA approved label to internal and external stakeholders according to SOP

•    Lead the Local Labelling Committee (including but not limited to medical, legal, commercial, safety) for the creation, review and approval for the Japan Labeling in the appropriate ECMS and according to SOP. This may also include discussion with relevant cross-functional SMEs and Japanese Health Authorities 

•    Key point of contact for the Japan Artwork for GRA and external stakeholders (medical, legal, commercial, safety, quality.

•    As Japan labelling & artwork expert for assigned Therapeutic Business Unit, 
•    the individual will build strong relationships with:
o    Japan and Global Regulatory teams
o    Local business partners (commercial, access, medical affairs, legal and understand their business needs
o    Key partner with SPA for labelling and artwork changes
•    Monitor changes in Japan labelling and artwork requirements – keep the organisation aware of changes in Japanese regulatory requirements.

Education Level : Bachelor's Degree

COMPETENCIES 
o    Build effective partnerships – identifies opportunities and takes actions to build effective relationships with internal and external stakeholders, gains trust and external networking,Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions. negotiation and influencing skills to develop regulatory strategies contributing to patient value creation
o    Flexibility and adaptability - Decides what to do based on the situation. Changes behaviour or approach to fit the situation or the person. Works effectively in ambiguous situations
o    Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate 
o    Results focused – ability to overcome obstacles and achieve key outcomes
o    Analytical – logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
o    Organizational Skills
o    Integrity – Commitment to integrity and high standards in self and othersRisk management: Anticipates, identifies characterizes and escalates risks associated with our products, processes and submissions. Identifies and defines research questions and strategy, relevant data sources, methodologies and systems for benefit, safety and Risk Minimization Measures (RMM) effectiveness analysis in a rapidly evolving environment
o    Leadership: Lead transversally beyond organizational borders, empower, hold accountable, drive innovation and engage around vision

Job Number: 1450

Community / Marketing Title: Japanese Labelling & Artwork Manager

Location_formattedLocationLong: Tokyo, Tokyo JP