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    Medical Information and Review- Senior Manager - Lexington, United States - BioSpace, Inc.

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    Job Details


    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use .

    I further attest that all information I submit in my employment application is true to the best of my knowledge.

    Job Description


    The purpose of this position is to 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.

    You will proactively manage Medical Information activities for specific products to include development of standard written and verbal responses with minimal supervision, including Clinical Dossiers, Letters and Frequently Asked Questions (FAQs), and periodic review of inquiries and responses.

    You will also 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.

    You will 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 pertinent publications in the therapeutic areas and serve as a resource to other colleagues as needed.


    Accountabilities:


    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.

    Coordinates efforts around Compendia submissions and product hot topics (ie saline shortage for Entyvio, product name changes etc). Craft s 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 kraft 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

    Education/Qualifications:

    Required:
    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 or more years of 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.

    Possess 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.

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

    Travel Requirements:
    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.

    Takeda Compensation and Benefits Summary

    We understand compensation is an important factor as you consider the next step in your career.

    We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.


    For Location:
    Lexington, MA

    U

    S Base Salary Range:
    $133, $209,000.00

    The estimated salary range reflects an anticipated range for this position.

    The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

    The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

    U.S. based employees may be eligible for short-term and/or long-termincentives.

    employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

    employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

    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.

    Locations

    Lexington, MA

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time
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