Senior Clinical Research Specialist

• Support clinical development programs for neurovascular therapies treating stroke and other neurovascular conditions
• Author and lead clinical, scientific, and regulatory documents, including clinical study protocols, clinical study reports, clinical evaluation reports, annual reports, risk-benefit assessments, and submission materials
• Develop clinical evidence strategies aligned with program objectives and regulatory requirements
• Partner with Clinical, Research & Development, Regulatory Affairs, Quality, Marketing, Sales, Compliance, and Health Economics & Reimbursement stakeholders
• Analyze and communicate clinical data through reports, presentations, and evidence summaries
• Conduct scientific literature reviews, clinical evidence assessments, and literature database management
• Lead publication planning and execution with physician investigators, key opinion leaders, and internal stakeholders
• Monitor and summarize emerging literature, conference presentations, and competitive developments in neurovascular therapeutics
• Manage multiple clinical and business-critical projects, coordinating reviews, feedback, revisions, and approvals

• Bachelor’s degree in a technical discipline and 4+ years of relevant clinical research, scientific writing, regulatory writing, or medical device experience; or an advanced degree and 2+ years of relevant experience
• Experience authoring or contributing to clinical, scientific, or regulatory documentation
• Experience supporting cross-functional projects within a regulated healthcare, life sciences, or medical device environment
• Ability to analyze, interpret, and communicate clinical or scientific data to diverse stakeholders
• Unrestricted U.S. work authorization required at the time of hire and for the duration of employment; sponsorship is not offered below Principal level
• For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
• Preferred: MD or PhD in a biomedical science discipline
• Preferred:
  Experience supporting clinical trials and clinical development programs within the medical device industry
• Preferred:
  Experience with clinical, medical, scientific, or regulatory writing and publication development
• Preferred:
  Neurovascular, stroke, vascular intervention, or related medical device therapeutic area experience
• Preferred:
  Experience supporting regulatory submissions and responses to health authorities

Demonstrates expertise in clinical research and regulatory writing, with a strong ability to analyze and communicate clinical data effectively. Proven experience in managing cross-functional projects within the medical device industry, particularly in neurovascular therapies.

• Clinical Research
• Regulatory Writing
• Scientific Writing
• Clinical Data Analysis
• Medical Device Experience

• Clinical Study Protocols
• Clinical Study Reports
• Clinical Evaluation Reports
• Risk-Benefit Assessments
• Submission Materials
• Literature Reviews
• Evidence Summaries
• Publication Planning
• Data Interpretation
• Project Management

• Communication
• Collaboration
• Stakeholder Engagement
• Analytical Thinking
• Organizational Skills

• Neurovascular Therapies
• Stroke
• Regulated Healthcare
• Life Sciences
• Clinical Trials
• Health Economics
• Reimbursement
• Medical Device Industry
• Regulatory Submissions
• Biomedical Science