Associate Director – Medical Information Lead - Japan

We are seeking a highly motivated individual to join us as the Japan Medical Information Lead. This position plays a pivotal role in ensuring the smooth running of the Japan Medical Information (MI) service and the co-management of the local MI team. In this role you will be a driver of change and thrive in a global environment where you play a key role in influencing without authority cross functionally.  

Job Overview 

• Overall accountability for the leadership and management of the MI service in the Japan affiliate 

• Accountable for ensuring inspection readiness of MI service in the Japan affiliate  

• Co-management of affiliate MI team member(s) along with International MI Region Lead 

• Accountable for ensuring that the MI function in the affiliate responds to unsolicited requests for information in an accurate, consistent, compliant, and timely manner 

• Ensure the identification, reporting and recording of adverse events and product complaints in a timely manner in accordance with procedural documents 

• Act as a point of contact with affiliate stakeholders to ensure the MI function supports adequately the needs of local teams 

Responsibilities 

Routine responsibilities may include the following: 

• Overall performance of the MI department/team in the affiliate 

• Along with International MI Region Lead, coach, and support the professional growth of Japan MI staff members 

• Develop and implement plan, in collaboration with the International MI Region Lead, to ensure the structure, scope, support model, and resources of the department can meet anticipated changes in workload 

• Work collaboratively with senior leadership, Japan Country Medical Director, and the TA leads in Medical Affairs to ensure the department is successfully supporting therapeutic area strategies, and influencing outcomes where required 

• Work cross functionally across the Gilead enterprise and represent GMI on larger initiatives.  Cross functional partners include, but are not limited to: Global Patient Safety, Quality and Medical Governance, Regulatory Affairs, Legal/Business Conduct, Medical Affairs 

• Work closely with the leaders of other GMI teams to ensure the practice of MI is consistently applied 

• Work closely with MI content leads and GMI TA teams to ensure appropriate MI response documents are available for use in Japan market, and that regulatory inspection expectations are met 

• Act as lead contact for MI function in the Japan affiliate for external regulatory inspections and the internal GxP audit program, liaising with direct reports and other functions as needed 

• Create, update, or implement policies, SOPs, business practices, and work instructions, as needed 

• Analyze departmental metrics so that patterns, trends, and issues are identified and shared with senior management and other internal stakeholders 

• Participate in global initiatives / working groups and projects, as needed 

Knowledge and Skills 

• Excellent leadership, interpersonal, and verbal and written communication skills 

• Demonstrate leadership at country level  

• Demonstrated ability to influence without authority, this is essential to be successful in this role 

• Proven track record in working in a dynamic,<s