Medical Information & Review Manager

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Job Description

About the role:

Join Takeda as a Medical Information & Review Manager where you will deliver high-quality, balanced and timely medical and scientific information regarding specific products, upon the request of internal and external business partners, health care professionals (HCPs) and consumers. You will also 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. As part of the US Medical team, you will report to the Director, US Medical Information & Review. This is a hybrid role based in Lexington, MA.

How you will contribute:

• Provide 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 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.  3) Other pertinent publications in the therapeutic areas as needed.

Accountabilities:

• Develop, maintain, and provide high quality medical and scientific information, 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 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

• Formulate 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.

• Support product booths at professional scientific meetings and train commercial colleagues about information request 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 delivers programs for ongoing training of departmental colleagues, Contact Center personnel, sales groups and support of Scientific Associate Directors.

• Serve as Medical Information representative at Medical Unit meetings.

• Develops strategies and initiatives that improve and streamline current processes with US Medical Affairs to improve medical information services to internal and external customers.

• Coordinate with medical affairs colleagues, vendor and outsource provider to develop content to be disseminated via multiple communication channels.

• Create, maintain and communicate metrics and key performance indicators to Senior Leadership.

Minimum Requirements/Qualifications:

Required:

• You will have a doctoral degree in a health sciences related field such as a PharmD, MD or Ph.D., w