Johnson & Johnson companies are equal opportunity employers.
Assoc Director Risk Management-4587130516
Description
Johnson & Johnson Consumer Products Company, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Risk Management located in Skillman, NJ.
Johnson & Johnson Family of Consumer Companies develops and markets OTC drugs, nutritional products, 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, TYLENOL® and MOTRIN ®products, ZYRTEC® and BENADRYL® allergy medicines, NEUTROGENA®, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR®.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Associate Director Risk Management (ADRM) is responsible for the review and analysis of any safety-associated issues that are or might be due to product quality issues, for the analysis of safety surveillance observations, and the response to safety inquiries from the Medical Safety Officer and internal and external authorities using internal and external post-marketing databases including AERS and MAUDE, the medical literature and exposure information for a wide range of cosmetic, OTC and medical device Personal Consumer products. The ADRM will report analysis results in support of signal detection and triage, health hazard / risk evaluations, risk management plans, regulatory submissions, label justification, and the assessment of safety profiles for all products in assigned franchises. In this role, the ADRM has a primary responsibility and accountability for the planning, tracking, archiving, quality and technical content of surveillance and aggregate and ad-hoc safety assessment reports. In addition, the ADRM may be expected to develop content of Risk Management Plans for technical documents; summarize ongoing projects for the global safety committee; create project summaries for documentation purposes; and, may assist in the management of safety issues from development through post-marketing.
The Associate Director Risk Management (ADRM) contributes to safety report strategy and planning. (S)he initiates searches of post-marketing databases and related product vigilance sources, customer response systems and Health Authority databases. This individual initiates searches of post-marketing databases and related product vigilance sources, customer response systems and Health Authority databases. (S)he prepares, drafts and writes scheduled and ad-hoc regulatory and aggregate reports, labeling, core data sheet updates and related documents. (S)he prepares safety documentation used in medical safety assessments, health hazard / risk evaluations, risk management plans, safety responses and other regulatory submissions. This person will represent the Medical Safety Officer as a participant in quality and safety committees to assist in safety issue management and signal escalation.
The Associate Director Risk Management (ADRM) conducts data compilation with Safety and QA input; interprets risk of product failure through design or manufacturing issue. (S)he conducts or directs searches of medical textbooks, reference sources (e.g. USP, CDC, AERS, MAUDE), and scientific literature. S(he) analyzes and interprets aggregate / tabulated safety surveillance data, lot trend and exposure information. S(he) identifies the need for, conducts, and summarizes case series reviews . (S)he evaluates and summarizes product efficacy data used in risk management plans or related documents.
Qualifications
This position requires a Bachelor degree in a technical, scientific, or related/equivalent discipline. A minimum of five (5) years of clinical development safety and/or post-marketing safety experience is required. A minimum of 5 years experience in management of broad-ranging product safety and development activities with decision-making responsibilities is required. Expert-level ability to search, analyze, interpret and clearly present safety, scientific and clinical data in written format is required. Proficiency in MS Outlook, Word, and Excel is desired. Excellent verbal and written communication skills are required. An advanced degree (e.g. M.D.,MPH, PharmD, MA or experience) in life sciences, Quality Assurance or health-care discipline is desired. Expertise and experience in Women's Health, dermatology, pharmacology, epidemiology, medical devices and/or decision sciences is desired. Prior team-managerial experience is desired. Medical writing experience is desired. Consumer Health experience is desired. There is a clear expectation that this person will be able to manage a flexible work schedule to accommodate off-hours meeting times is required. This position is located in Skillman, NJ. There is less than 10% domestic and /or international travel that is required.
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-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)
Job: Pharmacovigilance
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Assoc Director Risk Management-4587130516
Description
Johnson & Johnson Consumer Products Company, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Risk Management located in Skillman, NJ.
Johnson & Johnson Family of Consumer Companies develops and markets OTC drugs, nutritional products, 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, TYLENOL® and MOTRIN ®products, ZYRTEC® and BENADRYL® allergy medicines, NEUTROGENA®, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR®.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Associate Director Risk Management (ADRM) is responsible for the review and analysis of any safety-associated issues that are or might be due to product quality issues, for the analysis of safety surveillance observations, and the response to safety inquiries from the Medical Safety Officer and internal and external authorities using internal and external post-marketing databases including AERS and MAUDE, the medical literature and exposure information for a wide range of cosmetic, OTC and medical device Personal Consumer products. The ADRM will report analysis results in support of signal detection and triage, health hazard / risk evaluations, risk management plans, regulatory submissions, label justification, and the assessment of safety profiles for all products in assigned franchises. In this role, the ADRM has a primary responsibility and accountability for the planning, tracking, archiving, quality and technical content of surveillance and aggregate and ad-hoc safety assessment reports. In addition, the ADRM may be expected to develop content of Risk Management Plans for technical documents; summarize ongoing projects for the global safety committee; create project summaries for documentation purposes; and, may assist in the management of safety issues from development through post-marketing.
The Associate Director Risk Management (ADRM) contributes to safety report strategy and planning. (S)he initiates searches of post-marketing databases and related product vigilance sources, customer response systems and Health Authority databases. This individual initiates searches of post-marketing databases and related product vigilance sources, customer response systems and Health Authority databases. (S)he prepares, drafts and writes scheduled and ad-hoc regulatory and aggregate reports, labeling, core data sheet updates and related documents. (S)he prepares safety documentation used in medical safety assessments, health hazard / risk evaluations, risk management plans, safety responses and other regulatory submissions. This person will represent the Medical Safety Officer as a participant in quality and safety committees to assist in safety issue management and signal escalation.
The Associate Director Risk Management (ADRM) conducts data compilation with Safety and QA input; interprets risk of product failure through design or manufacturing issue. (S)he conducts or directs searches of medical textbooks, reference sources (e.g. USP, CDC, AERS, MAUDE), and scientific literature. S(he) analyzes and interprets aggregate / tabulated safety surveillance data, lot trend and exposure information. S(he) identifies the need for, conducts, and summarizes case series reviews . (S)he evaluates and summarizes product efficacy data used in risk management plans or related documents.
Qualifications
This position requires a Bachelor degree in a technical, scientific, or related/equivalent discipline. A minimum of five (5) years of clinical development safety and/or post-marketing safety experience is required. A minimum of 5 years experience in management of broad-ranging product safety and development activities with decision-making responsibilities is required. Expert-level ability to search, analyze, interpret and clearly present safety, scientific and clinical data in written format is required. Proficiency in MS Outlook, Word, and Excel is desired. Excellent verbal and written communication skills are required. An advanced degree (e.g. M.D.,MPH, PharmD, MA or experience) in life sciences, Quality Assurance or health-care discipline is desired. Expertise and experience in Women's Health, dermatology, pharmacology, epidemiology, medical devices and/or decision sciences is desired. Prior team-managerial experience is desired. Medical writing experience is desired. Consumer Health experience is desired. There is a clear expectation that this person will be able to manage a flexible work schedule to accommodate off-hours meeting times is required. This position is located in Skillman, NJ. There is less than 10% domestic and /or international travel that is required.
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-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)
Job: Pharmacovigilance
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.