Job Actions

Job Information

Manager, Global Aggregate Reporting
SKILLMAN NJ 08558
Category: Other
  • Your pay will be discussed at your interview

Job code: lhw-e0-89780857

Company Profile

J&J Family of Companies

Contact Company


Local Information

Laugh while you Look

Sponsored Ads

Summary

  Job posted:   Fri May 18, 2018
  Distance to work:   ? miles
       
  1 Views, 0 Applications  
 
Manager, Global Aggregate Reporting
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.




Qualifications



+ 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.




Primary Location

United States-Pennsylvania-Fort Washington

Other Locations

North America-United States-New Jersey-Skillman

Organization

J & J Consumer Inc. (6101)

Job Function

Drug & Product Safety Operations

Requisition ID

5074180306


More Information »