USA - Medical Information and Review Manager

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Objective:

The purpose of this position is to: 1) 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; 2) 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; 3) 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; 4) 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, and 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 Regional Medical Strategy Team 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 (internal, MICC, MedConnect).
• Create, maintain and communicate metrics and key performance indicators to Senior Leadership

Scope:

Number of Individuals Supervised:

Directly (range)

Indirectly (range)

Exempt, Manager/Supervisors

0

0

Exempt, Professional/Technical

0

1-2

Non-Exempt

0

2-4

Education, Experience and Skills:

Required:

• Doctorate degree

• The qualified candidate will have a doctoral degree in a health sciences related field such as a PharmD, MD or Ph.D., with a thorough grasp of the pharmaceutical industry.
• 1-2 years of healthcare or related experience (managed markets, clinical practice, research or academic) following award of doctoral degree.
• Possesses good communication skills, both oral and written, and able to engender trust and respect of peers, subordinates and superiors.
• Well-versed in highly technical and scientific languages in order to communicate with key Thought Leaders, Medical Affairs, Research and Development, as well as other key internal and external stakeholders.
• Firm understanding of the drug development process including key phases, processes, and techniques utilized for both pre- and post-marketing research studies.
• Proven track record of teamwork, leadership, timely decision making and results orientation in meeting objectives.
• Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.

Desired:

• Therapeutic area experience.
• Clinical, research, or teaching experience.
• Board Certification in therapeutic area of interest.

• Ability to drive to or fly to various meetings/client sites.
• Overnight travel (10-20%), including some weekend commitments.
• Travel may vary depending on therapeutic responsibilities.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.