Director, Clinical Evaluation Report Writing Services (Remote)
Company: Criterion Edge
Posted on: January 15, 2022
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
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
Specific responsibilities include:
Provide consistent, expert scientific oversight on all assigned
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
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
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
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
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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