Clinical Outcome Specialist Zeltiq Aesthetics, Inc.
THIS JOB HAS EXPIRED Description
Job Description: Clinical Outcome Specialist
Reports To: Director, Clinical Development
Department: Clinical Affairs
Responsible for the investigation and closure of clinical complaints globally. Also responsible for the monitoring of clinical trends through the complaint-handling process. Responsible for responding to clinical inquiries from physician users, patients or distributors.
Essential Duties and Responsibilities:
Receive and investigate all clinical complaints from physician users, patients or distributors.
Gather clinical information pertinent to each complaint and document in the SAP system.
Ensure timely complaint investigation, escalation and closure. Complete clinical complaint reports using FilePro Maker in a timely fashion upon closure.
Interface with complainants, Customer Service, Quality, Sales/PSS, Clinical departments as needed.
Assist with initial assessment of complaints for Medical Device Reporting and other regulatory reporting requirements.
Assist in general compliance activities as required.
Provide input to support the continual improvement of complaint handling processes.
Monitor clinical complaint occurrences and trends through the clinical complaint system. Identify any changes in the nature, severity, or frequency of side effects or other clinical complaints. Provide input into the identification of the root-cause of complaints.
Respond to clinical inquiries from physician users, patients or distributors in a timely fashion, in consultation with other resources, such as Clinical, Research and Development, as needed.
Perform all duties in accordance with the Company?s Quality Systems and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.
Perform other related duties as assigned
Two-year customer service and complaint handling experience required.
Working knowledge of relevant medical conditions and terminologies.
Must possess and demonstrate a strong customer-oriented attitude. Exhibits judgment and understanding of the issues; able to use reason even when dealing with emotional situations.
Ability to follow-through multiple projects simultaneously and set priorities with foreseeable time constraints.
Excellent interpersonal, oral and written communication skills
Must be proficient with MS Office, including Word and Excel.
Working knowledge of technologies and treatment modalities in the field of aesthetic medicine.
Experience in aesthetic practice setting strongly preferred.
Experience in handling complaints in a FDA-regulated environment and experience in MDR reporting highly desirable.
||Pleasanton, CA |
THIS JOB HAS EXPIRED