customer service iii.
waukegan , illinois
posted 1 day ago
job detailssummary
$20 - $25.38 per hour
contract
associate degree
category life, physical, and social science occupations
reference49604
job detailsjob summary:As the largest staffing and recruitment agency in the world, we can commit to finding 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, Illinoisjob type: Contractsalary: $20.00 - 25.38 per hourwork hours: 9 to 5education: Associateresponsibilities:The Device Tracking Analyst will communicate with customers to obtain and/or verify device tracking information in compliance with device tracking regulations established by the FDA and international regulatory bodies. He/she will facilitate actions identified to improve customer experience and patient safety. He/she will participate and/or lead in the identification and implementation of device tracking management system improvements, including technical support, and updates to procedures and forms used in the device tracking process. Assist globalization of requirements, where necessary. The individual is a subject matter expert due to demonstrated excellence in work performance and mastery of the knowledge, tasks, and skill sets. Works with little to no supervision.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.
qualifications:
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.
Knowledge in device tracking policies and requirements. Ability to understand the impact of regulatory compliance requirements (e.g. 21 CFR 821, 21 CFR Part 11, SOR/98/282 and other regulations as they )
Ability to function in a controlled environment by the FDA and other regulatory authorities.
Must have effective written/oral, interpersonal, organizational skills.
Ability to handle restricted, confidential, private, or personal information in accordance with departmental policies, HIPAA, and related international standards.
Knowledge of clinical, surgical techniques and procedures, and medical terminology.
Ability to work effectively with a diverse network of internal and external departments and/or individuals.
Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.
Skill in demonstrating a professional phone manner.
Effective communication with physicians and nurses as required.
Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
Ability to take initiative and make decisions.
Ability to demonstrate leadership in job performance by example.
Ability to accurately perform detail-oriented work.
Ability to be flexible in changing daily workload priorities as directed.
Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.
Ability to coordinate and synchronize multiple projects.
Ability to monitor and coordinate department workloads.
Ability to develop and deliver training.
Ability to manage a high-volume case load.
Ability to think critically and analytically.
skills: FDA, Regulatory Affairs OperationsEqual 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.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.
