Clinical Documentation Specialist, Professional Fee
University Hospitals
Senior Medical Writer
Artex Risk Solutions
full-time
Posted on:
Location: Florida • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Manage regulatory medical writing for international markets; write, edit, and review CEPs, CERs, PMCF plans, SSCPs, PMS plans, PMSRs, and PSURs in accordance with global regulatory requirements to support Arthrex’s regulatory compliance and global market sales.
- Collaborate with cross-functional teams (Regulatory, Clinical, Quality, Marketing) to ensure submission-ready clinical documentation; liaise with Project Manager and other cross-functional teams as applicable to provide input and gather required information.
- Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation; review or edit clinical regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures.
- Maintain periodic updates, perform gap analysis, and revise existing documents as necessary; participate in audits; may develop or conduct employee training.
Requirements
- Bachelor's degree in Life Science, Biological Science, or related discipline required.
- Advanced degree preferred, AMWA certification or RAC preferred.
- 5 years relevant experience required in clinical medical writing within the life science industry.
- EU MDR/MDD experience required.
- Clinical or statistical experience required.
- Experience authoring Clinical Evaluation Reports.
