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Director, Clinical Evaluation Report Writing Services (Remote)

Company: Criterion Edge
Location: Austin
Posted on: January 15, 2022

Job Description:

Job Type: Full-Time, Remote

Experience Level : Experienced

At Criterion Edge, we're committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology, and expertise, we empower healthcare companies to achieve their global regulatory goals with superior quality, speed, and budget control. Be on the leading edge by applying your regulatory writing expertise and leadership skills to the development, management and writing of regulatory-compliant Clinical Evaluation Report (CER) projects with top industry clients.

Criterion Edge (CE) is seeking a remote candidate for the role of Director, CER Writing Services. The position is responsible to provide management oversight and regulatory/scientific writing expertise to support and lead multiple CER writing projects that support EU MDR regulatory submission requirements for the client's portfolio of medical device products. Please note that previous CER writing experience and management of CER writers is required for this role.

Specific responsibilities include:
Provide consistent, expert scientific oversight on all assigned projects.
Collaborate with the Project Management team to assign appropriate writing resources to each project.
Oversee initial scoping of new projects and attend project kick-off meetings.
Mentor Principal Medical Writers and other writers that are assigned to the writing project. Assist medical writers with project related questions as needed.
Review regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs).
Conduct high level review and provide feedback to project team.
Review /oversee the systematic literature review process (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical devices.
Develop internal training resources and materials as needed and conduct training as needed
Provide input into company process development and improvement.
Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates.
Coach and mentor all project-related activities to ensure alignment with applicable regulatory requirements and Criterion Edge quality standards.

Required Experience:
Previous experience writing CERs and related documents in accordance with MEDDEV 2.7/1 rev 4 and EU MDR
Effective written, verbal and presentation skills in the area of technical/clinical applications
Strong command of medical and surgical terminology
Demonstrated ability to identify and adapt to shifting priorities and competing demands
Proven leadership in the management of teams
Highly skilled in document development and management using Word, Excel, PowerPoint and EndNote
Training and degree in science, engineering, or medical fields. Scientific/research background required, with a deep understanding of research design, methodology, and statistics

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Keywords: Criterion Edge, Austin , Director, Clinical Evaluation Report Writing Services (Remote), Healthcare , Austin, Texas

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