• Medical Writer and Publications Manager

    Job Locations US-WI-Madison
    Req No.
    2019-3297
    Category
    Medical Affairs
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    The Medical Writer and Publications Manager will lead the development, review, and submission of medical communications and publications relevant to Exact Sciences, Cologuard, and the company’s pipeline. This individual will work collaboratively and cross-functionally to manage publications that support and enhance the objectives of the Exact Sciences company-wide and Cologuard-specific evidence generation and publication plans.

    Essential Duties and Responsibilities

    • Manage the timely and successful development, execution, submission, and publication of publications that support Exact Sciences’ evidence generation and publication plan objectives
    • Leads the development of manuscripts, abstracts, posters, newsletters, and web content, including coordinating writing committees and creating, editing, and submitting content to scientific congresses and journals
    • Oversee document review cycles, including incorporating team comments and leading discussions on document revision and finalization
    • Accurately forecast and manage publication development and submission timelines and execute upon them
    • Support publication planning and design efforts, including partner identification, selection, and onboarding
    • Manage the day-to-day execution of a portfolio of publications that support evidence generation and publication plan objectives, including holding regular status update meetings with internal teams and external partners/vendors
    • Oversee all publication submission activities with scientific and medical journals, including ensuring timely follow-up on all submission-related deliverables and/or reporting requirements
    • Remain current with and adherent to all publication development requirements, timelines/milestones, and deliverables
    • Work collaboratively to meet publication development timelines and execute upon them
    • Proactively communicate setbacks or delays to all relevant parties
    • Coordinate activities with cross functional collaborators and external stakeholders, including but not limited to vendors, authors, journals, and publishers
    • Act as the day-to-day point of contact for publication-related external vendors and partners
    • Facilitate communication between internal and external teams to ensure there is a shared understanding of goals and objectives
    • Provide inputs to regular status updates on publication-related activities for internal and external stakeholders, including leadership and cross-functional updates
    • Ensure that all activities are in alignment with Evidence Generation and Publication Plan objectives
    • Ensure that publications and other documents comply with internal policies, procedures, and regulations
    • Ensure that the publication development process and all materials produced are in compliance with current relevant guidelines, including but not limited to the ICMJE, PhRMA, and GPP3
    • Lead the development and maintenance of planning documents, templates, style manuals, policies and procedures, and meeting materials that support the Medical Affairs Evidence Generation and Publication function
    • Develop an in-depth understanding of existing products and pipeline technologies
    • Actively participate as a member of the extended Medical Affairs Evidence Generation and Publication function: including participating in publication-specific meetings and teleconferences and providing clear and timely communication to team members and cross functional partners
    • Collaborate with Medical Affairs colleagues and work cross functionally with commercial team and other internal stakeholders, such as Marking, Corporate Affairs, Research & Development, Clinical and Regulatory Affairs, and Finance/Investor Relations
    • Support and comply with the company’s Quality Management System policies and procedures
    • Regular and reliable attendance
    • Ability to work normal schedule of Monday through Friday during normal business hours
    • Ability to work seated for approximately 90% of a typical working day. Ability to work standing for approximately 10% of a typical working day
    • Ability to work in front of a computer screen and/or perform typing for approximately 80% of a typical working day

    Qualifications

    Minimum Qualifications

    • Master’s Degree in Medical, Scientific or related field
    • 5+ years of relevant experience
    • Expert knowledge of relevant publication guidelines, including but not limited to International Committee of Medical Journal Editors (ICMJE), Pharmaceutical Research and Manufacturers of America (PhRMA), and the International Society for Medical Publication Professionals (ISMPP) Good Publication Practice (GPP3) guidelines
    • Excellent written, oral communication, and presentation skills
    • Superb attention to detail, notably through succinct, high-quality writing and strong organizational skills
    • Proven ability to work in teams
    • Self-starter with the ability to work independently
    • Experience in managing external vendors
    • Exceptional interpersonal skills and executive-level engagement
    • Experience in working with healthcare professionals
    • Proficient in a variety of computer software applications, including but not limited to: MS Word, Excel, Endnote, and PowerPoint
    • Ability to read, write, and speak English fluently
    • Authorization to work in the United States without sponsorship 

    Preferred Qualifications

    • PhD

    #LI-CJ1

    We are 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 are available to any applicant or employee for inspection upon request.

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