Tokyo, Japan
118 days ago
Associate Director, Medical Information
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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 affiliateAccountable for ensuring inspection readiness of MI service in the Japan affiliateDirect 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 mannerEnsure the identification, reporting and recording of adverse events and product complaints in a timely manner in accordance with procedural documentsAct 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 affiliateDevelop, coach, and support the professional growth of individual staff membersDevelop 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 workloadWork collaboratively with senior leadership, Japan Country Medical Director, and the TA leads in Medical Affairs to ensure the department is successfully supporting therapeutic area strategiesWork 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 AffairsWork closely with the leaders of other GMI teams to ensure the practice of MI is consistently appliedWork 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 metAct 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 neededCreate, update, or implement policies, SOPs, business practices, and work instructions, as neededAnalyze departmental metrics so that patterns, trends, and issues are identified and shared with senior management and other internal stakeholdersParticipate in global initiatives / working groups and projects, as needed

Knowledge and Skills

Excellent leadership, interpersonal, and verbal and written communication skillsDemonstrate leadership at country levelProven track record in working in a dynamic, cross-functional environmentHighly self-motivated and able to perform multiple tasks in a timely fashionExcellent project management, analytical, strategic-thinking, and problem-solving skillsKnowledge of applicable regulations regarding the dissemination of medical information, pharmaceutical industry promotional/non-promotional activities and adverse event and product quality complaint reportingKnowledge 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 equivalentTypically 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 preferredExperience in the pharmaceutical industry requiredExperience of working with MI vendors requiredPeople 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.


 


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