Endologix, Inc

  • Medical Writer

    Job ID
    2018-1838
    Location
    US-CA-Irvine
    Category
    Medical Affairs
  • Overview

    Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

     

    The Medical Writer will develop scientific manuscripts, presentations, and editorial for medical journals, scientific conferences and other academic venues that effectively and clearly describe the product performance and other medical information related to Endologix devices and therapeutic areas. A member of the Global Medical Affairs organization, collaborates closely with Medical Communications team, Chief Medical Officer, and several functional areas including Clinical, Regulatory, R&D, QA and Marketing to support Endologix podium and publication plans and editorial content. Position requires a working knowledge of vascular surgery and endovascular therapies, including the intended product use and best practices for Endologix devices.

    Responsibilities

    • Research, create, and edit scientific manuscripts and presentations based on input from the internal stakeholders and physicians.
    • Conduct literature searches on PubMed, MedLine or other similar medical literature databases; help to manage the literature database and prepare literature reviews for external and internal clients.
    • Track and report relevant clinical literature activity, independently develop literature summaries and analyze for internal stakeholders.
    • Independently review completed study data analysis draft reports and summary data for interpretation.
    • Prepare abstracts for submission to scientific congresses.
    • Develop podium presentations for sponsored and non-sponsored symposia.
    • Support Medical Communications team with physician requests for presentation content, which often requires development of presentations. Such presentation development typically entails independent research and analysis of the clinical literature, effective storyboarding.
    • Lead discussions on publication revision and finalization; coordinate and manage review processes, revise abstracts/presentation slides/manuscripts as per comments from internal & external reviewers.
    • Prepare all documentation (including identification and preparation of all supporting documentation and proof sources) for routing through the internal approval process as per company standard operating procedures.
    • Manage library of podium and product presentations for internal and external use.
    • Ensure that the documents and presentations comply with Quality Systems Regulations and applicable journal and other guidelines in terms of content, format and structure; Maintain awareness of ICMJE (Intl Committee of Medical Journal Editors) recommendations and ensure compliance with good publication practices (GPP).
    • Attend major national & international conferences to keep up to date with advancements in the field; contribute to the development of conference coverage reports for internal distribution.
    • Follow and enforce all corporate policies. 
    • 10-15 percent travel.
    • Maintain a high competency level relating to technical and clinical product information through reviewing of clinical literature, attendance at scientific meetings and preparation of medical communications in general.
    • The employee must possess sufficient authority for the recommendations to affect matters of consequence to the business or its customers. Duties would include advising management, negotiating, purchasing, representing the company, promoting sales, researching business opportunities, analyzing business data and determining company policies.
    • Perform other duties as assigned by supervisor.

    Qualifications

    • Working knowledge of statistics is required.
    • Proficient in Microsoft Office applications (Word, Excel, PowerPoint) and EndNote.
    • Highly proficient in the use of PowerPoint for medical communications.
    • Excellent project management and organizational skills.
    • Must be an excellent communicator in written and spoken form.
    • Candidate must be fluent in English.

    Education:

    • Bachelor’s degree required.
    • Advanced degree preferred (Ph.D., MD, Sc.D., M.S., M.P.H.)

    Experience:

    • At least 5 years’ experience in medical writing and presentation development for Medical or Clinical Affairs, or related functions, preferably as a medical writer for pharmaceutical, CRO, or medical device clients
    • Qualified candidates may have a background in biosciences, journalism or communications, health communications, technical writing, public health
    • Familiarity with the vascular / cardiovascular surgery, endovascular therapies or related field is strongly desired
    • Experience as author or contributor or peer-reviewed manuscripts is strongly desired.
    • Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases.

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