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Fort Washington, PA, US

Device Malfunction Operations Sr. Reporting Analyst-1941121204

Description

Johnson & Johnson Consumer Products Company, a member of the Johnson & Johnson family of companies, is recruiting for a Device Malfunction Operations Sr. Reporting Analyst for its location in Fort Washington, PA.

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S® Baby and BAND-AID® Brand, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR® and NEUTROGENA.

Reporting to the Associate Director Device Malfunction Operations (DMO) in the Office of Consumer Medical Safety (OCMS), the Device Malfunction Operations Sr. Reporting Analyst is the healthcare professional who, under the direction of the Associate Director, will be responsible for DMO policy, case auditing for quality and consistency with regulations and established procedures, all other activities related to the medical assessment of consumer devices for US FDA reporting requirements, and interface with Global partners. The Device Malfunction Operations Sr. Reporting Analyst will work closely with the Center for Global Surveillance in Manila and with the Monograph Drugs, Medical Devices and Cosmetics (MDC) Pharmacovigilance Operations.

Additionally, the Device Malfunction Operations Sr. Reporting Analyst, under the direction of the Associate Director, will participate in project management, training DMO personnel regarding regulations, case processing and good documentation practices, running and analyzing department metrics and auditing of case processing, facilitating the interface with global safety officers, assisting with process improvement initiatives, ad hoc reports and IT system initiatives.

Responsibilities of the Device Malfunction Operations Sr. Reporting Analyst include the following: monitoring of daily operations activities, including, but not limited to fielding and escalation of questions from the Global Surveillance Center in Manila; producing daily and ad hoc reports to monitor procedural timelines for case processing; facilitate review and writing of standard operating procedures for the Device Malfunctions Operations; oversee release of the documents through the document control system; maintain a listing of on-going projects related to departmental procedural enhancement; monitor activities and timelines, schedule meetings and author meeting minutes; collaborate with MDC case processing group, quality systems organization, research and development centers, and consumer care center; support training needs of Device Malfunction Operations to include assessment of training needs, drafting training materials, and facilitating delivery of training materials; and assist Associate Director in supporting department initiatives, including IT systems, CAPA related items and process improvements.

The Device Malfunction Operations Sr. Reporting Analyst will possess the ability to identify time critical deliverables, and prioritize/escalate to the Associate Director. This position supports and/or independently conducts searches of medical textbooks, reference sources (e.g. CDC, MAUDE, J&J Safety Databases), and scientific literature, including global legislation governing malfunction reporting and is responsible for analyzing and interpreting aggregate/tabulated device malfunction metrics using existing tools and/or identified malfunctions and narratives.

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Qualifications


A minimum of a Bachelor of Science (BS) degree in health care sciences is required for this position (e.g. Bachelor of Science in Nursing, Pharmacy or other Health Care Degree from an accredited institution). An advanced degree is preferred.

Experience in medical device surveillance and/or medical device malfunction reporting is required, as is a minimum of four (4) years of experience in marketed product safety for medical devices. Previous experience writing technical documents and familiarity with good documentation practices (GDPs) and document retention requirements is also required.

An advanced level skill in MS Outlook, Word, Excel and Access is preferred. Excellent verbal and written communication skills are required, as is a demonstrated ability in attention to detail and an eye for accuracy and previous experience working within highly regulated environment.

This position will be based in Fort Washington, PA and may require up to 10% travel in support of business needs.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: Johnson & Johnson Consumer Inc. (6071)