Clinical Research Medical Writer
- Draft and edit clinical study protocols, other study specific documents, clinical evaluation reports, and study reports
- Prepare regulatory submission documents, including 510(k) summaries, De Novo petitions, and labeling justifications
- Create safety narratives, informed consent forms, and patient-facing materials
- Collaborate with cross-functional teams (clinical operations, regulatory affairs, quality assurance) to gather data and ensure alignment
- Maintain document version control, formatting, and adherence to company and FDA standards
- Bachelor’s or advanced degree in Life Sciences, Nursing, Pharmacy, or related field
- 5+ years of medical writing experience in the medical device industry
- Proven track record preparing FDA 510(k) and De Novo submissions
- Familiarity with eCTD format, GCP, and ISO 14155 requirements
- Excellent scientific writing, editing, and project-management skills
- Strong attention to detail and ability to meet tight deadlines
Average salary estimate
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