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Senior Clinical Research Specialist
Medtronic. Lead development of clinical, scientific, and regulatory documents, including clinical study protocols, clinical study reports, clinical evaluation reports, annual reports, risk-benefit assessments, and submission materials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical, scientific, 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 and supporting regulatory submissions.
Highest-signal resume keywords
Clinical Study Protocol DevelopmentRegulatory WritingClinical Evidence Strategy DevelopmentCross-Functional Project ManagementNeurovascular Therapeutics Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical WritingScientific WritingRegulatory DocumentationClinical Trial SupportData AnalysisLiterature ReviewPublication PlanningRisk-Benefit AssessmentSubmission Materials DevelopmentClinical Evaluation Reports
Soft Skills
CommunicationCollaborationAnalytical ThinkingProject CoordinationStakeholder Engagement
Tools & Technologies
Literature DatabasesClinical Development ToolsRegulatory Submission Platforms
Industry Keywords
Medical DeviceLife SciencesRegulated HealthcareClinical DevelopmentHealth EconomicsReimbursementVascular InterventionStroke
About the role
Key responsibilities & impact- Lead development of 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
- Support clinical development activities
- Partner with Clinical, Research & Development, Regulatory Affairs, Quality, Marketing, Sales, Compliance, and Health Economics & Reimbursement teams
- Interpret, analyze, and communicate clinical data through reports, presentations, and evidence summaries
- Conduct scientific literature reviews and clinical evidence assessments
- Manage literature databases
- Lead publication planning and execution with physician investigators, key opinion leaders, and internal stakeholders
- Monitor and summarize emerging scientific literature, conference presentations, and competitive developments in neurovascular therapeutics
- Manage multiple clinical and business-critical projects, coordinating document reviews, feedback, revisions, and approvals
- Support study start-up, study execution, regulatory submissions, publication planning, and broader clinical development initiatives
Requirements
What you’ll need- 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
- 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 preferred
- For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Unrestricted U.S. work authorization required at the time of hire and for the duration of employment; sponsorship is not offered for roles below Principal level
- Ability to work onsite a minimum of four days per week
- Ability to travel approximately 25% based on business needs
Benefits
Comp & perks- Competitive benefits package
- Health insurance
- Dental insurance
- 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
- Capital Accumulation Plan
- Temporary employees eligible for paid sick time as required by applicable state law
- Employee Stock Purchase Plan for temporary employees