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
writing CERswriting PERssystematic literature reviewdata extractionstudy result interpretationliterature synthesisdocument developmentresearch designmethodologystatistics
Soft skills
effective written communicationeffective verbal communicationpresentation skillsadaptabilityleadershipteam managementcoachingproject oversightfeedback provisionprocess improvement