Manager Global Safety and Clinical Support
The Manager Safety champions product safety through involvement in the management of the clinical call center, risk management, clinical support, and clinical research.
As a Manager of the Clinical Call Center (CCC)
- Supervises the operation of the CCC, creates metrics, timelines, and implements Quality assurance and Quality control measures to ensure that the CCC provides optimal service to our internal and external customers.
- Supervises the schedule of the CCC to ensure 24/7/365 coverage.
- Provides information/ training to the CCC personnel to ensure they have the updated information on all the company’s products.
- Updates the CCC SOPs on a timely manner.
- Interacts with the National Call Center, Technical Support, and CCT groups to ensure the calls from our customers are transferred, responded and documented correctly and in a timely manner.
- Handling escalating issues and/ or calls, addressing and resolving them accordingly.
- Leads the team, sets objectives to be aligned with the department strategy, conducts performance reviews, and manages career development plans for the team which includes 4-5 direct reports.
As a Safety Manager
- Maintain thorough knowledge of the science of wound healing; in order to be an educated resource in products and treatment innovations in the health care industry. Advise Global KCI team members regarding questions and issues with wound care therapies, product knowledge, and product development.
- Develops risk assessments for innovation projects, including risk benefit analysis, post market surveillance and health hazard evaluations and literature reviews.
- Contributes to the update and development of clinical guidelines for company’s products.
- Coordinates and verifies the data captured for strat-map.
- Actively participates in Health Hazard Assessment/Evaluations and Corrective Actions related to marketed products.
- Conducts reviews of safety information as needed and contribute to the content of the product labeling by incorporating product safety knowledge (gained through interactions with the product users).
- Supports KCI internal trainings, the Training and Education Center, and Sales and Marketing groups by providing clinical expertise, knowledge and experience on all KCI products.
- Responds to safety, clinical and usage queries received from internal and external customers via clinical calls or emails
- Reviews accuracy of the clinical and safety content of literature), including communications to internal and external customers, regarding KCI therapies, product evaluation and data conclusions.
- Collaborates with other groups in the KCI Medical division, Marketing, Regulatory Affairs, Research & Development, Legal, labeling and Quality Assurance on various projects.
As a Member of the Infection Prevention and Control Activities group:
- Contributes to the development of safety protocols in relation to cleaning and management of KCI products for global service centers.
- Contributes to the development of guidelines for emergent infection prevention and control activities.
- Responds queries received from internal and external customers via clinical calls or emails regarding Infection and Prevention .
Skills and Experiences:
- Ability to handle the complexity of multiple projects
- Strong leadership and ability to work cross functionally
- Ability to lead a team and provide coaching to direct reports
- Strong communication skills
- Bachelors Degree in Nursing
- 6+ years work experience in the medical device or related industry
- Wound Management Experience
- Risk assessment experience
- Experience with Advance Wound Healing (AWT) products
- Experience in risk management of medical devices.
- Bachelors Degree in Nursing
Direct reports total of 4-5
The information listed above is not a comprehensive list of all duties/responsibilities performed.
This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice.The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor