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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Evidence activities, including authoring clinical investigational plans, clinical study reports, and regulatory submissions. Possesses strong analytical skills for interpreting clinical data and literature, along with effective communication abilities for presentations and collaboration with cross-functional teams.
Highest-signal resume keywords
Clinical Evidence ActivitiesMedical Writing ExperienceRegulatory SubmissionsData AnalysisNeurovascular Field Knowledge
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 Investigational PlansClinical Study ReportsLiterature ReviewsData AnalysisPublication StrategyScientific AnalysisRegulatory ResponsesClinical Evidence-Based DocumentsInterpreting Scientific InformationPreparing Presentations
Soft Skills
Excellent Communication SkillsAbility to Work in a Project TeamAbility to Work Under Pressure
Tools & Technologies
MS OfficeAdobe Acrobat
Certifications & Qualifications
PhDPharm.D
Industry Keywords
Medical Device IndustryClinical StudiesNeurovascular FieldClinical DataRegulatory Authority
About the role
Key responsibilities & impact- Lead implementation of Clinical Evidence activities
- Author clinical investigational plans and protocols for product approvals and expanded indications
- Author Clinical Evidence reporting deliverables, including Clinical Study Reports, regulatory responses, and related documentation
- Write literature reviews and summarize the state of the art for publications, study protocols, CSRs, and presentations
- Analyze results for product applications and submissions
- Collaborate with team members and stakeholders on Clinical Evidence projects and processes
- Support clinical, regulatory, quality, and engineering deliverables
- Maintain knowledge of assigned therapies and products and evaluate literature, clinical data, and medical references
- Analyze data and prepare presentations for clinicians and cross-functional teams
- Develop podium presentations and execute publication strategy
- Lead publications for clinical study data, coordinating with investigator authors and reviewing abstracts and manuscripts
- Serve on study teams and provide scientific support for trial design and scientific analysis
- Analyze literature and competitive information across products and therapies
- Support regulatory submissions and respond to regulatory-authority questions
- Prepare data for meetings with the FDA
- Perform other related duties and responsibilities
- Report to the Director of Clinical Evidence
Requirements
What you’ll need- PhD, or Pharm.D preferred; other advanced Medical or Life Sciences degrees may be considered
- Minimum 5 years’ experience in Medical Device Industry in designing and reporting on clinical studies
- Minimum 2 years of medical writing experience writing CIPs and CSRs
- Considerable experience interpreting scientific/clinical study information
- Considerable experience writing clinical evidence-based documents and documents supporting regulatory submissions
- Excellent communication skills
- Comprehensive knowledge of the neurovascular field preferred
- Ability to work well in a project team environment
- Ability to work under pressure in a dynamic, timeline-driven environment
- Demonstrated MS Office and Adobe Acrobat software skills
Benefits
Comp & perks- Meaningful work contributing to improving patient lives
- Close-knit, mission-driven team
- Recognition of work
- Respectful multicultural community
- Employee care and support across countries
- Equal Employment Opportunity employer
