Medical Writer
BD
full-time
Posted on:
Location Type: Hybrid
Location: Tempe • Arizona • United States
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About the role
- Prepare and update EU Clinical Evaluation Reports (CERs) and summarize relevant literature to support technical files, dossiers, registrations, and other regulatory documentation
- Coordinate with a variety of cross-functional partners (e.g., Regulatory, R&D, Clinical Affairs, and Quality) to access and identify necessary preclinical, clinical, and technical information
- Generate and track timelines, follow through on tasks and ensure high-quality results
- Develop or revise templates, SOPs, or guidelines for regulatory, medical, or clinical documentation
- Conduct scientific literature reviews and compile reports, including literature updates and periodic safety updates
- Lead routine systematic literature reviews for specific medical device groups or sub-groups, write and edit scientifically complex documents for substantial intellectual content.
Requirements
- Bachelor’s degree in the sciences, medical-related field, or medical/technical writing
- 1-3 years of medical device experience OR at least 5 years of medical device experience
- Experience or understanding of scientific or clinical research and methods
- Working knowledge of Microsoft Office Products
- Ability to interpret statistical results of clinical studies and summarize findings clearly and accurately
- Ability to collaborate effectively with Medical Writing team members and cross-functional stakeholders.
Benefits
- Health insurance
- Flexible work hours
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Evaluation Reportsscientific literature reviewsregulatory documentationmedical writingstatistical analysisclinical research methodsSOPsguidelines developmenttechnical writing
Soft Skills
collaborationcommunicationorganizationattention to detailleadership