Associate Director, In Vitro Diagnostic Regulation – Writing Services
Criterion Edge
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- Provide consistent, expert scientific oversight on all assigned projects.
- Collaborate with the Resourcing team to assign appropriate writing resources to each project.
- Oversee initial scoping of new projects and attend project kick-off meetings.
- Review regulatory documents and responses to regulatory authorities, specifically working on Performance Evaluation Reports (PERs).
- Conduct high level review and provide feedback to project team.
- Review/oversee the systematic literature review process (e.g. screen articles against inclusion/exclusion criteria, extract data from included studies, interpret study results, synthesize literature, and prepare summaries into formal reports) for IVDs.
- Provide input into company process development and improvement.
- Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates.
- Coach all project-related activities to ensure alignment with applicable regulatory requirements and Criterion Edge quality standards.
Requirements
- Previous experience writing CERs and/or PERs and related documents in accordance with MEDDEV 2.7/1 rev 4 and/or EU MDR and/or EU IVDR
- Effective written, verbal and presentation skills in technical/laboratory diagnostics
- Strong command of medical and laboratory 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 field(s).
- Scientific/research background required, with a deep understanding of research design, methodology, and statistics
Benefits
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
writing CERswriting PERssystematic literature reviewdata extractionstudy result interpretationliterature synthesisdocument developmentresearch designmethodologystatistics
Soft Skills
effective written communicationeffective verbal communicationpresentation skillsadaptabilityleadershipteam managementcoachingproject oversightfeedback provisionprocess improvement