Case Processor Iii (100 % Remote )

Job Title         :  Case Processor III (100 % remote )

Location         :  North Chicago Illinois USA 60064

Duration         : 12 Months Contract (with possible extensionn

Job Description 

Does this position offer the ability to work remotely on a regular basis or is it an on-site role: Remote regular basis
 What are the top 5 skills/requirements this person is required have?
a. Required Skill 1: Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation
b. Required Skill 2: 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)
c. Required Skill 3: Ability to Problem Solve Independently & with Others - Highly Skilled
d. Required Skill 4: Execution / Results / Process Improvement - Highly Skilled
e. Required Skill 5: Cross Functional Relationships and communication skills - Highly Skilled
7) What years of experience, education, and/or certification is required?
Bachelor of Science
8) What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Argus, 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
Biomedical engineer or RN preferred
9) What is the environment that this person will be working in (i.e., group setting vs individual role)?
Individual setting, Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day)
10) Is any testing required for this role?
No
11) Other notable details about the environment from the hiring manager about this role.
None
12) What positions/background experience do you feel are successful in this role
Medical Device Risk Management
Medical Device complaint handling
Medical Device literature searches/reviews
Experience/Skills
Bachelor of Science
Biomedical engineer or RN preferred
Medical Device Risk Management experience preferred
Medical Device complaint handling experience preferred
Medical Device literature searches/reviews experience preferred
Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Argus, 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
Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation
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)
Ability to Problem Solve Independently & with Others - Highly Skilled
Execution / Results / Process Improvement - Highly Skilled
Cross Functional Relationships and communication skills - Highly Skilled
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 PPS 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.
Activities performed under this team:
Assisting with ongoing continuous improvement projects spanning across departmental needs
Providing support for training and automation efforts
Identify regional label variances and build tool to capture info for priority products and main competitors
Support medical safety consultation activities in matters related to risk/benefit, proper product safety usage as needed and complaint assessments
Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products
Participate in root-cause investigations into device failures and human factors-related use errors.