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Job Description

Associate Director – Medical Information Lead Japan affiliate

We are seeking a highly motivated individual to join us as the Japan Medical Information Lead. This position is responsible for the smooth running of the Japan Medical Information (MI) service and the management of the local MI team.

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
• Direct management of affiliate MI team member(s)
• 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
• Develop, coach, and support the professional growth of individual 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
• 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
• Proven track record in working in a dynamic, cross-functional environment
• Highly self-motivated and able to perform multiple tasks in a timely fashion
• Excellent project management, analytical, strategic-thinking, and problem-solving skills
• Knowledge of applicable regulations regarding the dissemination of medical information, pharmaceutical industry promotional/non-promotional activities and adverse event and product quality complaint reporting
• Knowledge of industry Medical Information common practices, adverse event and product complaint reporting.

Education and Experience

• Pharmacy, Nursing or Medical/ Life Sciences degree/advanced degree or equivalent
• Typically requires 6+ years relevant pharmaceutical industry or similar experience. An advanced degree (PharmD, MD) is preferred.
• Experience in Medical Information, call center management and oversight is required.
• Experience in leadership in MI or working in a healthcare environment required, with country / affiliate experience preferred

• Experience in the pharmaceutical industry required
• Experience of working with MI vendors required
• People management experience required

Equal Opportunities
As an equal opportunity employer, Gilead Sciences is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable laws. It is also Gilead’s policy to comply with all applicable laws respecting consideration of unemployment status in making hiring decisions.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.