What are the responsibilities and job description for the Medical Reviewer position at Orion Group?
Location: Remote
Contract Length: 12 Months
Pay Rate: $40-45/hr including individual healthcare coverage
Candidates MUST come from a Registered Nurse background
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 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
- Strategic Decision Making and Negotiation
- Facilitating Change and managing conflicts
- Ability to Problem Solve Independently & with Others
- Business Organization & Industry Awareness
- Cross Functional Relationships and communication skills
- Execution / Results / Process Improvement
Background / Required and Preferred Education Level:
- Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing
- RN Required
Salary : $40 - $45
