Johnson & Johnson Careers
Medical Events Liaison (1 of 2)
Requisition ID: 4111180613
Johnson & Johnson Vision (JJV), a member of Johnson & Johnson's Family of Companies is recruiting for Medical Events Liaison, to be located in Santa Ana, CA with consideration for remote locations in the United States.
JJV, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the JV brand, and fortifying our position as the worldwide leader in total eye healthcare solutions.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
You, the Medical Events Liaison will:
- Chairs and participates in the rapid response team cross functional meetings and facilitates discussion and workflow.
- Prioritizes, coordinates, develops and conveys responses (verbal and/or written) to customer complaints summarizing investigation status updates and investigation summaries/conclusions.
- Uses clinical ophthalmic experience to act as a liaison and key resource for customers and eye care professionals regarding product performance issues; train eye care professionals and other product safety personnel on use of products in accordance with approved labeling
- Positively interacts with the customer and eye care professionals, educates and advises on proper use of JJ Vision products.
- Acts as a partner for the commercial team with escalated issues
- Coordinates and dictate the cadence or prioritization of investigations in association with manufacturing sites and complaint lab
- Handles calls determined to be difficult or highly sensitive (during triage) from eye care professionals and patients and process those complaint folders per procedural guidelines
- Intakes, evaluates and makes MDR/Global vigilance reporting decisions related to customer complaints
- Reviews medical complaints, assigns appropriate classification, manages workflow and determines filing requirements. Files / submits regulatory reports to the appropriate worldwide regulatory bodies within the required time lines
- Coordinates and leads responses to FDA Additional information letters and responses to other Health Authority or Notified Bodies
- Supports MDR/global reportability decisions with clinically sound justification. Documents this justification in position papers.
- Supports audit related activities pertaining to complaints and MDR determination rationales etc.
- Adheres to GMP regulations within complaint and medical files and other documents within the department.
- Peer review / audit of medical reportable files ensuring accurate submission to regulatory bodies.
- Leads or participates in other activities as required including reviewing new / emerging regulations, project teams, training new associates, process improvements, etc.
- Works in a cooperative and collaborative manner with fellow team members through constructive communication, flexibility, and exhibits a willingness to assist other team members.
- RN or BS Degree preferred or 3-5 years related medical experience in an Ophthalmic surgery center
- 3-5 years medical device related experience
- Minimum of 6 years work experience.
written and oral communication skills in English
- Strong interpersonal and organizational skills
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-California-Santa Ana
AMO US Holdings, Inc.. (6234)