Senior Manager, Medical Information & Review

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Job Description

About the role:

Join Takeda as a Senior Manager, US Medical Information and Review where you will deliver high-quality, balanced and timely medical and scientific information regarding specific products and provide advanced medical and scientific review of promotional and medical materials. Additionally, serve as a technical and/or operational resource, upon the request of internal and external business partners, health care professionals (HCPs) and consumers. As part of the US Medical team, you will report to the Director, US Medical Information and Review. This is a hybrid role based in Lexington, MA.

How you will contribute:

• Manage Medical Information activities for specific products to include development of standard written and verbal responses, including Clinical Dossiers, Letters and Frequently Asked Questions (FAQs), and periodic review of inquiries and responses.

• Provide advanced medical information / clinical expertise for assigned products to internal (Medical Affairs strategy teams, Therapeutic Area Units within R&D, commercial Brand teams) and external stakeholders such as healthcare professionals, patients and advocacy groups.

• Provide advanced medical and scientific review of 1) promotional materials, press releases, and sales training communications to support the promotional review process, 2) medical and scientific slides housed in the Medical Affairs slide repository, and 3) other relevant publications in the therapeutic areas and serve as a resource to other colleagues.

Accountabilities:

• Utilizing advanced medical information /clinical expertise develops, maintains and provides high quality medical and scientific information autonomously, including Standard and Custom Response Letters, Clinical Dossiers, and FAQs, to both internal and external customers.

• Grant formal approval via signature authority for the cross-functional promotional review activities including: 1) providing strategic scientific consultations on brand messages, 2) reviewing promotional materials for content and accuracy, 3) coordinating the development and review and approval of clinical data on file to support promotional claims.

• Drive innovation by integrating AI technologies to streamline medical information review processes, optimize medical review workflows, and leverage data-driven insights to support faster, more informed cross-functional decision-making.

• Coordinate efforts around Compendia submissions and product hot topics (i.e. product name changes etc.).

• Responsible for vendor and partnership (if applicable) management during dossier updates.

• Applies clinical expertise and knowledge to craft medical responses and recommendations (including errata) as requested by scientific journals and organizations.

• Direct and coach the Medical Information Contact Center staff on handling of “routine” cases; monitor and manage complex “escalated” cases from the Medical Information Contact Center.

• Coach and mentor fellows, students and Medical Information & Review Managers.

• Provide advanced support to product booths at professional scientific meetings and train commercial colleagues on possible responses to complex, unique information requests procedures and issues at sales meetings to assure legal and regulatory compliance.

• Conducts strategic assessment (gap analysis) of medical information needs within the therapeutic area and develops fulfillment strategies.

• Enhance medical and product knowledge within the broader organization by disseminating actionable medical insights on a consistent basis.

• Develop and deliver programs for ongoing train