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 with computer (Word, PowerPoint, Excel, etc.)

• Able to assess problems and overcome objections.

• Professional attitude and appropriate business and clinical judgment in all aspects of this position.

• Must be able to collaborate with all levels of the organization and with customers at various levels of the health care facility (clinical staff, biomed, C-suite, risk management).

• Must have effective interpersonal, telephone, and communication skills (both written and verbal).

• Working experience with various software programs, including MS Office (Word, PowerPoint, Excel, and Outlook) required. Experience with TrackWise, SAP, MS Teams, preferred.

• Specific knowledge of the Pyxis Dispensing Systems, preferred.

Knowledge and Skills:

• Effective oral and written communication skills targeted at all levels within the company. 

• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.

• Demonstrated ability to manage, develop and mentor exempt and non-exempt level personnel both inside and outside the department reporting structure.

• Project management utilizing analytical, technical, and problem-solving skills. 

• Able to perform multiple complex tasks & prioritize workloads & activities for large volumes of complaints.

• Strong organizational skills & proven ability to meet deadlines in an environment of competing priorities.

• Excellent computer skills (Including but not limited to: Microsoft Office, Minitab, SAP, TrackWise)

• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.

• Demonstrated ability to successfully interact with regulatory authorities during inspections & audit related to complex technical documentation; defending failure investigation activities as failure investigation SME during inspections is a plus.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers 

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 

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Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$124,100.00 - $204,800.00 USD Annual