Job Description:
- The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives.
- The team is a high-profile high-impact team that works with PSEQ functions on a range of product initiatives.
- As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients.
Experience & Skills:
- Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation, Case processing of Device SAE/AEs, device complaints and SADE potential cases
- Knowledge of Research & Development and an understanding of regulatory guidelines / requirements related to R & D Medical Devices / Combination Products (e.g., ICH, GCP, CFR, EU-MDR, safety reporting)
- Clinical Trial Experience
- Clinical Trial Device Experience
- Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Veeva, Argus, EDC Rave, Veeva EDC other database tools)
- Ability to effectively interact with and influence others without direct reporting relationships
- Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs
Core Essential Skills:
- Ability to Meet Challenging Milestones with results orientation – Skilled
- Strategic Decision Making and Negotiation – Skilled
- Facilitating Change and managing conflicts – Skilled
- Ability to Problem Solve Independently & with Others - Highly Skilled
- Business Organization & Industry Awareness - Highly Skilled
- Cross Functional Relationships and communication skills - Highly Skilled
- Execution / Results / Process Improvement - Highly Skilled
Background / Required and Preferred Education Level:
- Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing
- RN Required
Job Types: Full-time, Contract
Pay: Up to $51.93 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- Health insurance
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
Experience:
- Data analysis skills: 5 years (Required)
- Research & development: 5 years (Required)
- Clinical trials: 4 years (Required)
- electronic databases: 4 years (Required)
Work Location: Remote