Senior Clinical Research Specialist - NV - Irvine, CA; Lafayette, CO or Fridley, MN (Onsite)
Core
Lead the development of clinical, scientific, and regulatory documentation to support the global clinical development of neurovascular therapies for stroke and other conditions.
Role type
Senior Clinical Research Specialist (Scientific Writing & Evidence Generation)
Builds
Clinical study protocols, clinical study reports, clinical evaluation reports, annual reports, risk-benefit assessments, and submission materials for regulatory and commercialization activities.
Domain
Healthcare / Medical Devices / Neurovascular Therapies
Required skills
Clinical research, scientific writing, regulatory writing, medical device experience, cross-functional project management, data analysis and interpretation, literature review, publication planning
Preferred skills
MD or PhD in biomedical science, clinical trial support, regulatory submissions experience, neurovascular/vascular intervention therapeutic area knowledge
Technologies
None explicitly listed
Responsibilities
Author and lead development of clinical and regulatory documents; Develop clinical evidence strategies; Partner with cross-functional stakeholders; Interpret and communicate clinical data; Conduct scientific literature reviews; Lead publication planning; Monitor emerging scientific literature; Manage multiple clinical projects
Seniority
Senior, hands-on IC
