Job Description Summary

The Manager, Clinical Specialist Team is responsible for overseeing the team of Clinical Specialists who are tasked to gather facts on customer issues related to adverse events and managing customer relationships by providing a high-level of customer service. The individual must have a customer centric focus while interacting with customers, as well as other team members in professional services and quality. Effective interpersonal skills and professional customer communication skills (verbal & written) are required for outbound customer calls to obtain adverse event details in a timely and expeditious manner.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Manage, mentor, and orient the team of Clinical Specialists; assist with outbound follow-up phone calls (in lieu of emails) to the healthcare facility on adverse event complaints to gain pertinent information quickly.

• Collaborate with professional services and Designated Complaint Handling Unit (DCHU) teams to obtain investigative details on complaints from the healthcare facility.

• Work collaboratively with BD investigative lab to pass on any pertinent details quickly from customer calls or correspondence.

• Monitor any death or serious injury medical device report (MDR) records through investigation completion to closure ensuring that the adverse event information is comprehensive and meets target timeframes for closure.

• Follow up with internal teams (i.e., complaint lab) and HCL associates to process adverse events to closure within a target timeframe of <45 days by tracking each complaint.

• This position will be a subject matter expert for audits or assessments on adverse events.

• This role will organize a team of internal individuals to meet on Additional Information inquiries from health authorities to draft responses for review by internal teams.

• Ability to review and summarize medical journal articles received throughout BD on Dispensing Systems to assess if they represent reportable adverse events for medical device reporting.

• Incorporate site visit information from on-site teams into complaints, and write and submit

• Raise awareness of adverse events to legal, corporate, and management teams.

• Prepares weekly death or serious injury MDR adverse event lists for monthly Dispensing post market surveillance reports, ensuring any clinical and legal reviews/comments/corrections are incorporated into the reports.

• Expedites any death eMDR submissions for clinical and legal review prior to a timely submission of the report to the FDA.

• Periodically review and revise MDR Reportability Guideline to incorporate current failure modes and reportability determinations, expediting the procedural changes through document control.

• Work with HCL associates to ensure changes to automated tools are updated based on updated work instructions and MDR Reportability Guidelines.

• On occasion, may work with Escalation team to visit or attend a conference with the customer.

• Ability to multi-task and work in a fast-paced environment with critical importance on timely MDR submissions.

• Overtime may be required on occasion to meet regulatory submission time frames.

• Work collaboratively with the Leadership of CPC and TPC teams regarding forwarding customer questions both clinical and technical. Also, to be able to identify and refer customers to these teams for potential education or on-site visits.

Education and Experience:

• A Bachelor's Degree in Nursing required and must be a Registered Nurse.

• A minimum of 3 years of professional experience directly related to the degree.

• Experience in supervision; experience in managing a medical device reporting team is a plus.

• Ability to collect, analyze and present clinical data. Must be proficient