• Medical Information, Content and Medical Legal Regulatory (MLR) Specialist

    Job Locations US-WI-Madison
    Req No.
    2018-2842
    Category
    Medical Affairs
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    The Content and Medical, Legal, Regulatory (MLR) Specialist serves as the frontline clinical subject matter expert in the provision of clinical and medical information to the commercial and laboratory organizations. This role is responsible for providing direct support to the content creation, delivery and management within the organization. This role liaises with all commercial functions in the review for scientific and medical accuracy for a variety of audiences prior to and through the MLR review process. The management of medical information is a core function of the Medical Affairs department with strong cross-functional alignment.

    Essential Duties and Responsibilities

    • Leads development, management and maintenance of Medical Information database/repository with accurate, evidence-based and balanced scientific/medical information for intra-departmental and cross-functional utilization, both written and verbal
    • Serves as a team and cross-functional point-person for review and advisement related to scientific accuracy in advance of MLR submissions
    • Works with cross-functional leads to ensure that materials are compliant with FDA regulations
    • Leads and develops updates and additions to product Dossiers in collaboration with Medical Writer and Content Manager
    • Develops, reviews and/or delivers scientific resources used for product/disease state slide decks, sales training content and medical education initiatives
    • Serves as the frontline specialist for engaging healthcare provider and/or delegate customers in clinical dialogue that results from medical inquiries through the Provider Support, sales and medical affairs teams
    • Utilizes appropriate information resources to provide timely, accurate, thorough and balanced information to build and update medical information in all Commercial and Medical Affairs materials in accordance with internal policies and regulatory guidelines (PhRMA, AdvaMed)
    • Collaborates with the Medical Information team in the development and updating of standard clinical replies, FAQ documents and clinical information in training materials for the sales force
    • Collaborates with the Medical Information Specialist –Lab and CE Liaisons to ensure that all clinical information and product information is harmonized and consistent across all functional areas
    • Assists with and contributes to other scientific communications and Medical Affairs activities
    • Bidirectionally interacts with key Commercial and Laboratory stakeholders to ensure proper utilization and dissemination of medical content
    • Establishes and maintains SOPs and processes to support the MLR review and Medical Information functions
    • Maintains knowledge base of evolving medical evidence and evidence in collaboration with the Medical Information team and appropriately transmits knowledge base
    • Assists in the maintenance of key resource documents for the Medical Affairs team, including but not limited to, Dossiers, databases and endnote libraries
    • Supports MSL and Medical Director efforts related to medical presentation development and delivery
    • Collaborates with the Commercial and Laboratory teams on HCP facing correspondence, materials and collateral
    • Demonstrates the ability to organize and prioritize assigned workload and employ efficient time management strategies when performing medical information activities
    • Conducts business in accordance with Exact Sciences’ values
    • Completes all assigned trainings and professional development requirements

    Qualifications

    Education and Experience

    • Bachelor's of Science in Nursing or Bachelor's of Science or Master of Science in life sciences
    • Five (5) years of experience in related field of expertise
    • Previous experience with medical information and/or content management within the pharma/biotechnology space
    • Excellent written and verbal communication skills
    • Results-driven and highly motivated; committed to achieving goals and passionate about furthering the Exact Sciences mission
    • Strong attention to detail with a focus on producing high quality work
    • Superior customer service skills; proven track record of fostering relationships, establishing partnerships and collaborating on projects with stakeholders across multiple segments
    • Ability to interface and work effectively across multiple, cross-functional teams
    • Demonstrated competence using information technology, MS WORD, MS EXCEL, PCs and databases; advanced proficiency in Microsoft PowerPoint and EndNote
    • Superior interpersonal, problem solving and decision-making skills
    • Proven track record with high level prioritization skills, multi-tasking and project management
    • Strong command of medical terminology, pathophysiology, statistics

    Preferred

    • GI experience; knowledge of US regulatory standards related to communication and dissemination of medical information

    Physical Requirements

    • Ability to lift and move up to 40 pounds on an occasional basis
    • Ability to use computers and telephone daily in an interactive manner for extended periods of time and up to 8 hours a day
    • Constant walking or motion to communicate work and interact with co-workers
    • Travel requirements are infrequent <10%; position located in Madison, WI

    #LI-JK1

    Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program is available to any applicant or employee for inspection upon request. 

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed