Johnson & Johnson companies are equal opportunity employers.
Associate Director, Aggregate Reporting, Consumer Medicinal Products-1439140203
Description
Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc., is recruiting for an Associate Director, Aggregate Reporting, Consumer Medicinal Products, in Horsham, PA.
Johnson & Johnson Consumer Products Company, a 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 Visine® and BAND-AID® Brand, as well as leading skin care brands such as Cortaid®, KY® and Listerine Brand®.
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, Consumer products Aggregate Reporting (AD.CAR) is the senior aggregate reporting expert and supervisor of other Consumer products Aggregate Reporting (CAR) staff in the review, analysis and regulatory reporting of aggregate adverse event reports for the medicinal products of the Johnson & Johnson Family of Consumer Companies that are managed in the SCEPTRE safety system. The ideal candidate will have a demonstrated ability to provide technical as well as managerial leadership as subject matter expert for aggregate reporting to a global staff of employees, individual contractors and contract resource organizations. The AD.CAR provides subject matter expertise and technical guidance on functional requirements and enhancements to meet emerging global regulatory requirements and implementation of a global aggregate reporting solution; monitors compliance metrics; and, implements corrective and preventative actions to remediate non-conformance issues.
The AD.CAR is accountable for the aggregate analysis and regulatory reporting activities for Consumer Medicinal products. The primary accountability of the AD.CAR is to establish and oversee end-to-end aggregate reporting management and reporting processes and ensure compliance with regulatory reporting requirements worldwide and departmental Standard Operating Procedures (SOP). This position will directly or indirectly oversee all staff involved in aggregate analysis and reporting for consumer medicinal products. Close working relationships (involving several time zones) with the Associate Director Pharmacovigilance Physicians for Consumer Medicinal Products and Medical Safety Officers, with management and staff of the OCMS Center for Global Safety in Manila, and safety service providers in Asia Pacific; as well as with the Qualified Person for Pharmacovigilance (QPPV) Consumer, and Safety Compliance leadership are critical. Interactions with medical and regulatory staff of Operating Companies and with colleagues responsible for Safety Informatics, Operations, Surveillance, and Decision Analytics, as well as Medical Regulatory Sciences, Pharma Global Medical Operations, the Consumer Care Center, Regulatory Affairs and Quality Assurance are expected to occur regularly.
The AD.CAR develops quality systems and procedures for the aggregate analysis and reporting of adverse effects related to medicines, to assure regulatory compliance with company standards and regulatory requirements. Duties and responsibilities of the AD.CAR may include, but are not limited to: Ensures consistency in global processes by establishing guidelines for clear procedures and overseeing the development of appropriate measures, standard operating procedures and other work practices. Performs as lead subject matter expert (SME), and manages participation of aggregate reporting staff in quality and compliance audits and inspections. Provides effective responses to internal and external audits of aggregate reporting activities and the corrective actions arising from these audits. Delivers aggregate assessments for individual case safety reports from clinical trials and post-marketed products by managing multidisciplinary project teams including NA, EMEA and/or AP based company or outsourced operations. Contributes metrics to quarterly annual reports and coordinates accuracy and timeliness. Ensures that reporting timelines are met and reported internally. Prepares global aggregate reports and submissions to local authorities. Controls and assures the quality of the scientific and material content of any documents, files, or other materials sent to regulatory agencies. Independently identifies information impacting product safety of new and marketed products and escalates findings to management following company procedures. Trains self, employees and contractors on their pharmacovigilance responsibilities prior to work engagements; updates training of self and others as required on an annual basis in compliance with schedules and regulations.
Qualifications
An advanced degree (e.g. MS, MPH, PharmD; or worldwide equivalent from an accredited institution) in a human health, regulatory compliance, or management of operations related field, with sound knowledge of aggregate reporting operations is required. A minimum of eight (8) years of direct or related experience in marketed product safety for medicinal products, medical devices and/or cosmetics is required. A minimum of four (4) years of technical as well as managerial leadership as subject matter expert for aggregate reporting to a global staff of employees, individual contractors and contract resource organizations is required. Expert level knowledge and hands-on experience in aggregate case safety report information collection, case level analysis, medical writing, facilitating physician review, archiving and documentation, submission to health authorities and compliance management is required. An advanced level understanding of international pharmacovigilance regulations is required. Demonstrated success in global operations, team and people management; insight and examples of application of management skills required to lead global, outsourced operations is required. An advanced level working knowledge of safety databases to identify inefficiencies or the need for system enhancements; in particular, experience in SCEPTRE and/or ARGUS safety systems is required. Excellent written and verbal communication skills in English is required. A demonstrated ability to create or improve safety aggregate analysis and reporting operations is preferred. Experience with Consumer Medicinal Product safety, medical affairs, clinical research, or regulatory affairs is preferred. This position is located in Horsham, PA. There will be up to 20% domestic and international travel.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-Pennsylvania-Horsham
Organization: Johnson & Johnson Consumer Inc. (6071)
Job: Drug & Product Safety Science
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.
Associate Director, Aggregate Reporting, Consumer Medicinal Products-1439140203
Description
Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc., is recruiting for an Associate Director, Aggregate Reporting, Consumer Medicinal Products, in Horsham, PA.
Johnson & Johnson Consumer Products Company, a 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 Visine® and BAND-AID® Brand, as well as leading skin care brands such as Cortaid®, KY® and Listerine Brand®.
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, Consumer products Aggregate Reporting (AD.CAR) is the senior aggregate reporting expert and supervisor of other Consumer products Aggregate Reporting (CAR) staff in the review, analysis and regulatory reporting of aggregate adverse event reports for the medicinal products of the Johnson & Johnson Family of Consumer Companies that are managed in the SCEPTRE safety system. The ideal candidate will have a demonstrated ability to provide technical as well as managerial leadership as subject matter expert for aggregate reporting to a global staff of employees, individual contractors and contract resource organizations. The AD.CAR provides subject matter expertise and technical guidance on functional requirements and enhancements to meet emerging global regulatory requirements and implementation of a global aggregate reporting solution; monitors compliance metrics; and, implements corrective and preventative actions to remediate non-conformance issues.
The AD.CAR is accountable for the aggregate analysis and regulatory reporting activities for Consumer Medicinal products. The primary accountability of the AD.CAR is to establish and oversee end-to-end aggregate reporting management and reporting processes and ensure compliance with regulatory reporting requirements worldwide and departmental Standard Operating Procedures (SOP). This position will directly or indirectly oversee all staff involved in aggregate analysis and reporting for consumer medicinal products. Close working relationships (involving several time zones) with the Associate Director Pharmacovigilance Physicians for Consumer Medicinal Products and Medical Safety Officers, with management and staff of the OCMS Center for Global Safety in Manila, and safety service providers in Asia Pacific; as well as with the Qualified Person for Pharmacovigilance (QPPV) Consumer, and Safety Compliance leadership are critical. Interactions with medical and regulatory staff of Operating Companies and with colleagues responsible for Safety Informatics, Operations, Surveillance, and Decision Analytics, as well as Medical Regulatory Sciences, Pharma Global Medical Operations, the Consumer Care Center, Regulatory Affairs and Quality Assurance are expected to occur regularly.
The AD.CAR develops quality systems and procedures for the aggregate analysis and reporting of adverse effects related to medicines, to assure regulatory compliance with company standards and regulatory requirements. Duties and responsibilities of the AD.CAR may include, but are not limited to: Ensures consistency in global processes by establishing guidelines for clear procedures and overseeing the development of appropriate measures, standard operating procedures and other work practices. Performs as lead subject matter expert (SME), and manages participation of aggregate reporting staff in quality and compliance audits and inspections. Provides effective responses to internal and external audits of aggregate reporting activities and the corrective actions arising from these audits. Delivers aggregate assessments for individual case safety reports from clinical trials and post-marketed products by managing multidisciplinary project teams including NA, EMEA and/or AP based company or outsourced operations. Contributes metrics to quarterly annual reports and coordinates accuracy and timeliness. Ensures that reporting timelines are met and reported internally. Prepares global aggregate reports and submissions to local authorities. Controls and assures the quality of the scientific and material content of any documents, files, or other materials sent to regulatory agencies. Independently identifies information impacting product safety of new and marketed products and escalates findings to management following company procedures. Trains self, employees and contractors on their pharmacovigilance responsibilities prior to work engagements; updates training of self and others as required on an annual basis in compliance with schedules and regulations.
Qualifications
An advanced degree (e.g. MS, MPH, PharmD; or worldwide equivalent from an accredited institution) in a human health, regulatory compliance, or management of operations related field, with sound knowledge of aggregate reporting operations is required. A minimum of eight (8) years of direct or related experience in marketed product safety for medicinal products, medical devices and/or cosmetics is required. A minimum of four (4) years of technical as well as managerial leadership as subject matter expert for aggregate reporting to a global staff of employees, individual contractors and contract resource organizations is required. Expert level knowledge and hands-on experience in aggregate case safety report information collection, case level analysis, medical writing, facilitating physician review, archiving and documentation, submission to health authorities and compliance management is required. An advanced level understanding of international pharmacovigilance regulations is required. Demonstrated success in global operations, team and people management; insight and examples of application of management skills required to lead global, outsourced operations is required. An advanced level working knowledge of safety databases to identify inefficiencies or the need for system enhancements; in particular, experience in SCEPTRE and/or ARGUS safety systems is required. Excellent written and verbal communication skills in English is required. A demonstrated ability to create or improve safety aggregate analysis and reporting operations is preferred. Experience with Consumer Medicinal Product safety, medical affairs, clinical research, or regulatory affairs is preferred. This position is located in Horsham, PA. There will be up to 20% domestic and international travel.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-Pennsylvania-Horsham
Organization: Johnson & Johnson Consumer Inc. (6071)
Job: Drug & Product Safety Science
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.