- Design clinical studies and evidence strategies supporting global regulatory submissions
- Act as a scientific and clinical liaison with regulatory bodies and external sites
- Partner cross-functionally with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams
- Author and review clinical and regulatory documentation to support product clearance and commercialization
- Build strong internal and external collaborations and mentor junior scientists
Requirements
- Bachelor's degree in Life Sciences, Healthcare, or a related field with 9+ years of experience in clinical research
- Significant experience in US and/or EU trials
- In-depth understanding of clinical study design and methodology in diagnostics, medical device, or pharmaceutical industry
- Ability to identify and solve complex issues in clinical trial conduct
- Excellent communication (written and verbal) and interpersonal skills
Core Competencies
Demonstrates expertise in clinical study design and methodology, with a strong focus on regulatory submissions and cross-functional collaboration. Proven ability to mentor junior scientists and effectively communicate with regulatory bodies and internal teams.
Highest-signal resume keywords
- Clinical Study Design
- Regulatory Submissions
- Cross-Functional Collaboration
- Clinical Research Experience
- Communication Skills
ATS Optimization Keywords
Hard Skills
- Clinical Research
- Study Methodology
- Regulatory Documentation
- Evidence Strategies
- Problem Solving
Soft Skills
- Interpersonal Skills
- Mentoring
Industry Keywords
- Life Sciences
- Healthcare
- Diagnostics
- Medical Device
- Pharmaceutical Industry
- US Trials
- EU Trials
Principal Clinical Scientist in town of florida at Unknown Company
This position is listed as full time and onsite.