Senior Specialist, Medical Writing, Remote US
Core
Develop regulatory and clinical documents, including clinical evaluation reports and study reports, to support the development of transcatheter heart valve therapies.
Role type
Senior Specialist, Medical Writing (Clinical Science)
Builds
Regulatory and clinical evidence packages for Transcatheter Mitral and Tricuspid Therapies (TMTT)
Domain
Medical Device / Cardiovascular Therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Systematic literature search, clinical data extraction, medical writing, regulatory document development, cross-functional stakeholder management
Preferred skills
Advanced degree (Master's/PhD), experience with PubMed/Embase, authoring clinical evaluation reports, cardiovascular therapeutic area knowledge, familiarity with MEDDEV 2.7/1 and EU MDR, FDA PMA application experience, scientific research methodology, GCP, ICH guidelines
Technologies
MS PowerPoint, MS Word, MS Excel, EndNote, Adobe Acrobat
Responsibilities
Perform systematic literature searches and extract relevant clinical data; develop routine and moderately complex medical writing documents; review and provide feedback on cross-functional deliverables; negotiate deliverables and timelines with stakeholders; implement continuous process improvements
Seniority
Senior, hands-on IC
