Director, Medical Information & Review

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Job Description

OBJECTIVES: 

The Director, Medical Information & Review will work closely with the Sr Director, Medical Information & Review and assigned US Medical Team(s) to lead a high performing team responsible for medical information and medical review activities across a broad portfolio of products within a given therapeutic area. The Director will also support implementation of US Medical communication strategies and other scientific communication activities as identified.

ACCOUNTABILITIES: 

• Proactively manages medical information personnel and activities for assigned products in therapeutic area to include development of written and verbal responses, including clinical dossiers.
• Responsible for ensuring team provides high-quality, balanced and timely medical information for multiple products upon the request of internal and external business partners, health care professionals (HCPs) and consumers. Serves as a technical and/or operational resource for direct reports.
• Collaborates directly with medical strategy (Medical Director, Scientific Director) personnel in the development / execution of medical communications and research activities and leads operational and scientific projects aligned with company objectives and alliance partnerships for assigned therapeutic area.
• Manage Medical Review personnel in the participation and contributions to cross-functional promotional review activities including: 1) providing strategic scientific consults on brand messages, 2) reviewing promotional materials for content and accuracy, 3) coordinate the development and review and approval of clinical data on file to support promotional claims.
• Leads the Medical Review process, procedures, and documentation of Non-Promotional Medical Review of Medical Materials in partnership with internal stakeholders. Medical Materials may include medical slides, medical training materials, medical education materials, white papers, publications, and other types of medical and scientific material.
• Leads, manages, coaches and develops Medical Review personnel to support high performance, alignment with USM Medical Strategies, and support the delivery of high-quality product information, promotional product communications, and other medical and scientific communications. Assesses performance against identified Medical Review functional goals. Create, maintain and communicate metrics and key performance indicators to Leadership.
• Maintains current and up to date knowledge on FDA Regulations and Guidance documents and enforcement action letters as applicable to promotional claims and shares implications with Medical Reviewers to enhance the team’s knowledge, understanding, and awareness of best practices.
• Supports the development of (Sr) Medical Information & Review Managers by supporting training activities to develop direct reports.
• Assess new alliance partnerships for resource needs; develops appropriate joint Medical Review policies/processes; collaborates with Sr Director, Medical Information and Review and alliance partner in the development of policies/processes that reflect best practices and are in compliance with Takeda policies/processes.
• Works closely with Scientific Communications Leadership Team to ensure standardization within the Medical Information and Review function of defined policies, SOPs, and best practices.
• Ensures overall team is maintaining a comprehensive knowledge of therapeutic area, product(s), and health ecosystem developments by participating in relevant team and company meetings, attending scientific congresses, and a commitment to continued profession