Senior Manager, US Medical Information and Review

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 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.

• 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.

• Utilize advanced medical information / clinical expertise to develop, maintain and provide high quality medical and scientific information autonomously, including Standard and Custom Response Letters, Clinical Dossiers, and FAQs, to both internal and external customers. Coordinate efforts around Compendia submissions and product hot topics (e.g., product name changes). Craft medical responses and recommendations (including errata) as requested by scientific journals and organizations.
  
  Responsible for vendor and partnership (if applicable) management during dossier updates.
• Grant formal approval via signature authority for cross-functional promotional review activities, including providing strategic scientific consultations on brand messages, reviewing promotional materials for content and accuracy, and coordinating the development and review and approval of clinical data on file to support promotional claims.
• Apply clinical expertise 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 routine cases; monitor and manage complex escalated cases.
• Represent US Medical Affairs at Global Core Response Document meetings with authority to approve Core Responses.
• Coach and mentor interns, 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 information requests while ensuring legal and regulatory compliance.
• Conduct strategic assessment (gap analysis) of medical information needs within the therapeutic area and develop 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 training of departmental colleagues, Contact Center personnel, sales groups and support of Scientific Associate Directors.
• Serve as Medical Information subject matter expert representative at Regional Medical Strategy Team meetings.
• Medical review of materials pertinent to Takeda business as required, including Medical Education materials and internal medical and scientific slides, papers, and manuscripts.
• Proactively identify and develop 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, vendors and outsource providers to develop content to be disseminated via multiple communication channels (internal, MICC, Med Connect).
• Create, maintain and communicate metrics and key performance indicators to Senior Leadership.

• Doctoral degree in a health-sciences related field such as a Pharm
  
  D, MD or PhD, with a thorough grasp of the pharmaceutical industry.
• 2-3 years of healthcare or related experience (managed markets, clinical practice, research or academic) following award of doctoral degree including a minimum of 2 years of medical communications experience within the pharmaceutical industry.
• Proficiency in using AI tools to drive efficiency and innovation is desired.
• Advanced communication skills, both oral and written, and ability to engender trust and respect among peers, subordinates and superiors.
• Well-versed in highly technical and scientific languages to communicate with key Thought Leaders, Medical Affairs, R&D, and…