job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!
location: Waukegan, Illinois
job type: Contract
salary: $20 - 24 per hour
work hours: 9 to 5
- Process and maintain device tracking files in the device tracking system to support compliance with device tracking regulations and internal procedures. Ability to analyze information for device tracking requirements under 21 CFR 821 and SOR/98-282.
- Initiate device tracking files when forms are received in a timely manner. Maintain and update device tracking system. Record all activity in both hard copy (when applicable) and computer files.
- Maintain a knowledge and understanding of current Device Tracking regulations, Device Tracking guidelines, and Device Tracking interpretations.
- Provide generalized company, departmental and device tracking knowledge as required.
- Coordinate with inter- and intra-departmental customers to ensure device tracking information and inquiries are communicated appropriately.
- Handle sensitive conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service, effectively utilizing "talking points" and communicating corporate policy.
- Support department processes and workflow
- Process outgoing faxes, incoming mail, perform data entry, filing and copying.
- Initiate and process follow up activities to gather information, submit notifications, etc.
- Inform internal and/or external customers of the device tracking requirements.
- Ability to monitor several files at once, including status and follow-up as necessary.
- Respond to verbal and written requests from internal and external customers. Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files, following complaint handling regulations 21 CFR 820.198, and SOR/98-282, and internal procedures.
- Ability to identify non-complaint customers and forward to management for resolution.
- Provide assistance with various departmental projects that may include:
- Write/revise department procedures as assigned.
- Assist in the coordination of department personnel regarding device tracking and/or complaint handling activities to ensure compliance with applicable regulations.
- Develop training content.
- Train new staff and conduct training/re-training on company policies, Device Tracking regulations, complaint handling regulations, and departmental practices.
- Support the department on special projects as needed.
- Assist in device tracking audit activities.
- Support regulatory inspections.
- AA degree, with three to five years previous experience in regulatory, quality, clinical, or related customer service setting; or equivalent combination of education and experience.
- Bachelor's degree is strongly preferred.
skills: MS-WORD, MS-EXCEL, MS-Powerpoint
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.