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Manager, Global Aggregate Reporting
Requisition ID: 5074180306
Johnson & Johnson Consumer Products Company, a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, Global Aggregate Reporting to be based in Fort Washington, PA or Skillman, NJ.
Johnson & Johnson Family of
Companies touches more than a billion people’s lives each day through our
health care products and services, our corporate giving, and the volunteer
efforts of our employees. The Johnson & Johnson Group of Consumer Companies
develop and market beloved brands that address the needs of consumers and
health care professionals worldwide. Our portfolio ranges across several
distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty,
Feminine Care, and Over-The-Counter (OTC) products.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Manager, Global Aggregate Reporting, Johnson & Johnson Consumer Inc. supports the Associate Director in all activities associated with the aggregate analysis and regulatory activities for medicinal (MED) OTC products, the Manager, Global Aggregate Reporting, is an aggregate reporting expert in the review, analysis and regulatory reporting of aggregate adverse event reports for Johnson & Johnson Consumer Inc. Consumer medicinal products. The Manager, Global Aggregate Reporting has 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 Manager, Global Aggregate Reporting provides subject matter expertise and technical guidance on functional requirements and enhancements to meet emerging global regulatory requirements and implementation of global aggregate reporting solutions and training; monitors compliance metrics; and implements corrective and preventative actions to remediate non-conformance issues.
- Provide oversight of staff involved in aggregate reporting for consumer medicinal products.
- Develop quality systems and procedures for the aggregate analysis and reporting of adverse effects related to Consumer medicinal products, to assure regulatory compliance with company standards and regulatory requirements.
- Ensure the compliance (quality, procedures, regulations, consistency) of aggregate reports is met.
- Controls and assures the quality of the scientific and material content of any documents, files, or other materials sent to regulatory agencies.
- Performs management review of all vendor produced materials, i.e., draft reports and assessment responses.
- Prepares global aggregate reports for local authorities.
- Independently identifies information impacting product safety of new and marketed products and escalates, as needed, following company procedures.
- Daily management of vendor activities and responsibility for compliance with SOPs, global regulations/guidelines by either onsite or offshore resources.
- Develops and coordinates processes for offshore vendor.
- Performs training, onboarding, and oversight of offshore vendor.
- 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.
- Represents Aggregate Reports in cross-developmental and cross-company teams.
- Contributes metrics to quarterly annual reports and coordinates accuracy and timeliness.
- Ensures reporting timelines are met and reported internally.
- A minimum of a Bachelor’s Degree in Health or Biomedical Science is required.
- Graduate Degree in Health or Biomedical Science preferred.
- A minimum of 3 years of pharmaceutical industry experience is required.
- A minimum of 2 years of experience in pharmacovigilance is required.
- Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements is required.
- Attention to detail along with strong scientific, analytical and conceptual skills is required.
- Ability to understand complex medical-scientific data from a broad range of disciplines is required.
- Understand aspects and methods for data analysis, interpretation and presentation is required.
- Ability to effectively interact with external stakeholders, including business partners is required.
- Ability to manage/lead in a matrix environment is required.
- Demonstrated success in global operations, team and people management is preferred.
- Knowledge of global regulatory framework for aggregate safety reports is preferred.
- Experience in developing aggregate safety reports (e.g., PBRER/PSUR, PADER) is preferred.
- Up to 10% travel (international and domestic) is required.
United States-Pennsylvania-Fort Washington
North America-United States-New Jersey-Skillman
J & J Consumer Inc. (6101)
Drug & Product Safety Operations