Senior Neurovascular Clinical Research Lead

Medtronic plc

Lafayette (CO)

On-site

USD 106,000 - 158,000

Full time

4 days ago
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Job summary

Medtronic plc in the United States is seeking a Senior Clinical Research Specialist to lead the development of clinical, scientific, and regulatory documentation for neurovascular therapies.

Based in Fridley/Mounds View, Irvine, or Lafayette, CO, the role follows a flexible onsite model with travel ~25%. You will partner across Clinical, R&D, Regulatory, Quality, Marketing, Sales, and Health Economics to advance evidence generation and regulatory submissions.

Qualifications

  • 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.

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.

Skills

Clinical research
Scientific writing
Regulatory writing
Cross-functional collaboration

Education

Bachelor's in technical discipline

Tools

Job description

Medtronic plc in the United States is seeking a Senior Clinical Research Specialist to lead the development of clinical, scientific, and regulatory documentation for neurovascular therapies.

Based in Fridley/Mounds View, Irvine, or Lafayette, CO, the role follows a flexible onsite model with travel ~25%. You will partner across Clinical, R&D, Regulatory, Quality, Marketing, Sales, and Health Economics to advance evidence generation and regulatory submissions.

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