About the role:
Join Takeda as a Senior Medical Information & Review Manager where you will be responsible for the strategic development and delivery of Medical Information assets and medical review of medical/promotional materials for scientific rigor, accuracy with the therapeutic area landscape, and compliance with regulatory requirements. As part of the US Medical team, you will report to the Director, Medical Information & Review. This is a hybrid role based in Lexington, MA.
How you will contribute:
Deliver high-quality, balanced medical and scientific information regarding specific products upon the request of internal and external business partners, health care professionals (HCPs) and consumers.
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.
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. Coordinate efforts around Compendia submissions and product hot topics (i.e. product name changes etc.). 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 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
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.
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, 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 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 other materials pertinent to Takeda business as required, including Medical Education materials and internal medical and scientific slides/papers/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, 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.
You 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.
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.
Has advanced 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.
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.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Flexible Ways of Working
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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.Locations
Lexington, MAWorker Type