What are the responsibilities and job description for the Customer Service III position at TekWissen LLC?
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This Client's mission is to discover and deliver innovation medicines and solutions that address complex health issues and enhance people's lives.
Position: Customer Service III
Location: North Chicago, IL, 60085
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Job Description:
- 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.
KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:
- % of Time or Importance
- Process and maintain device tracking files in the device tracking system to support compliance with device tracking regulations and internal procedures.
- Ability to analyse 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.
25%
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.
JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
- The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Education and Experience
- 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.
ESSENTIAL SKILLS:
- 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 apply)
- Ability to function in a controlled environment by the FDA and other regulatory authorities.
- Ability to communicate effectively, both verbally and in writing.
- 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.
What are the top 3-5 skills, experience or education required for this position:
- Critical thinking skills to problem solve or identify when to escalate
- Ability/experience in working both independently and as a team
- Experience in working in a controlled/regulated environment (e.g. federal/state regulations, privacy)
- Experience in customer service, especially communicating sensitive information over phone in email with tough calls
- Minimum associate's degree; bachelor degree preferred
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Salary : $15 - $21
