Role Summary
Senior Manager, US Medical Information and Review at Takeda. 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. Serve as a technical and/or operational resource for internal and external partners, healthcare professionals, and consumers. Hybrid role based in Lexington, MA.
Responsibilities
- Manage Medical Information activities for specific products, including development of standard written and verbal responses, Clinical Dossiers, Letters and FAQs, and periodic review of inquiries and responses.
- Provide advanced medical information / clinical expertise for assigned products to internal strategy teams and external stakeholders such as healthcare professionals, patients and advocacy groups.
- Provide advanced medical and scientific review of promotional materials, press releases, and sales training communications; review medical slides and other relevant publications; serve as a resource to colleagues.
- Develop, maintain and provide high quality medical and scientific information autonomously (Standard/Custom Letters, Clinical Dossiers, FAQs) for internal and external customers.
- Grant formal approval for cross-functional promotional review activities, including strategic scientific consultations on brand messages and reviewing promotional materials for content and accuracy.
- Coordinate development, review and approval of clinical data on file to support promotional claims.
- Drive innovation by integrating AI technologies to streamline medical information review processes and optimize workflows.
- Coordinate efforts around Compendia submissions and product hot topics; manage vendor/partnerships during dossier updates.
- Apply clinical expertise to craft medical responses and recommendations as requested by journals and organizations.
- Direct and coach Medical Information Contact Center staff on routine cases and manage escalated cases.
- Coach and mentor fellows, students and Medical Information & Review Managers.
- Support at professional meetings and train commercial colleagues on complex information requests to ensure regulatory compliance.
- Conduct strategic gap analyses of medical information needs and develop fulfillment strategies.
- Disseminate actionable medical insights to enhance knowledge across the organization.
- Develop and deliver ongoing training programs for departmental colleagues, Contact Center personnel and sales groups.
- Represent the Medical Information and Review function at US Medical Unit meetings; review other materials as required.
- Identify and develop strategies to improve current processes with US Medical Affairs to enhance medical information services.
- Coordinate with Medical Affairs, vendors, and outsource providers to disseminate content via multiple channels.
- Create, maintain and communicate metrics and KPIs to Senior Leadership.
Qualifications
- Required: Doctoral degree in a health-sciences field such as PharmD, MD or PhD; 2–3 years of healthcare or related experience post-degree, including at least 2 years in medical communications within the pharmaceutical industry.
- Required: Advanced communication skills (oral and written) and ability to engage diverse stakeholders.
- Required: Proficiency in communicating using highly technical and scientific language; understanding of the drug development process.
- Required: Demonstrated teamwork, leadership, timely decision-making and results orientation; proficiency in Microsoft Office.
- Preferred: Clinical, research, or teaching experience; Board Certification in therapeutic area.
Skills
- Medical information management
- Clinical and scientific review
- Strategic communication
- AI-enabled process improvement
- Vendor and project management
- Training and mentoring
- Regulatory compliance in medical communications
Education
- Doctoral degree in a health-sciences field (PharmD, MD or PhD)
Additional Requirements
- Travel: Ability to drive to or fly to various meetings/client sites; overnight travel 10–20%, including some weekends; travel may vary by therapeutic responsibilities.