Clinical Research Medical Writer

ROLE OVERVIEW :

We’re seeking an experienced Clinical Research Medical Writer to support a high-visibility medical device project. You will develop clear, compliant, and scientifically rigorous documentation across the product lifecycle, including submissions to the FDA (510(k) and De Novo).

KEY RESPONSIBILITIES :

• 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

QUALIFICATIONS :

LOCATION : Plano TX, Frisco TX, or Allen TX, or the surrounding area

POSITION : Part-time, Hybrid