Senior Clinical Research Specialist

Jobtailor; California (MO); On-site; USD 110,000 - 165,000; Full time

Job summary

Jobtailor is seeking a senior clinical/regulatory writer to support neurovascular therapy programs. You will author and lead essential clinical, scientific, and regulatory documents and coordinate with cross-functional teams to ensure rigorous documentation and submission readiness.

The role emphasizes data interpretation, literature reviews, and publication planning with investigators and stakeholders, in a regulated medical device environment. US work authorization is required.

Qualifications

• Bachelor’s degree in a technical discipline with 4+ years of relevant clinical research, scientific writing, regulatory writing, or medical device 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.

Responsibilities

• Support clinical development programs for neurovascular therapies treating stroke and other neurovascular conditions.
• Author and lead clinical, scientific, and regulatory documents, including study protocols, 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.

Skills

Clinical Research

Regulatory Writing

Scientific Writing

Clinical Data Analysis

Medical Device Experience

Education

Bachelor's degree in technical discipline

MD or PhD preferred

Job description

• 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

Requirements

• 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

Core Competencies

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.

Highest-signal resume keywords

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

ATS Optimization Keywords

Hard Skills

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

Soft Skills

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

Industry Keywords

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