Senior Clinical Research Specialist - NV - Irvine, CA; Lafayette, CO or Fridley, MN (Onsite)
About The Position
The Neurovascular Clinical Research team supports the global clinical development of therapies designed to treat stroke and other neurovascular conditions. This team partners across Clinical, Research & Development, Regulatory, Quality, Health Economics & Reimbursement, Marketing, and Medical Affairs to generate clinical evidence that supports product development, regulatory submissions, and commercialization activities. The Senior Clinical Research Specialist supports clinical development programs by leading the development of clinical, scientific, and regulatory documentation while partnering with cross-functional stakeholders to advance evidence generation strategies. This role contributes to study start-up, study execution, publication planning, regulatory submissions, and broader clinical development initiatives supporting neurovascular therapies.
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.
Nice To Haves
- MD or PhD in a biomedical science discipline.
- Experience supporting clinical trials and clinical development programs within the medical device industry.
- Experience with clinical, medical, scientific, or regulatory writing and publication development.
- Neurovascular, stroke, vascular intervention, or related medical device therapeutic area experience.
- Experience supporting regulatory submissions and responses to health authorities.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Author and lead the development of clinical, scientific, and regulatory documents, including clinical study protocols, clinical study reports, clinical evaluation reports, annual reports, risk-benefit assessments, and associated submission materials.
- Develop clinical evidence strategies and support clinical development activities aligned with program objectives and regulatory requirements.
- Partner with cross-functional stakeholders across Clinical, Research & Development, Regulatory Affairs, Quality, Marketing, Sales, Compliance, and Health Economics & Reimbursement to support product development and lifecycle initiatives.
- Interpret, analyze, and communicate clinical data through clear and scientifically accurate reports, presentations, and evidence summaries for internal and external audiences.
- Conduct scientific literature reviews, clinical evidence assessments, and literature database management activities to support development and regulatory objectives.
- Lead publication planning and execution activities in collaboration with physician investigators, key opinion leaders, and internal stakeholders.
- Monitor and summarize emerging scientific literature, conference presentations, and competitive developments relevant to the neurovascular therapeutic area.
- Manage multiple clinical and business-critical projects simultaneously, coordinating document reviews, stakeholder feedback, revisions, and approval processes.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
