Janssen Research & Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Associate, Global Labeling Compliance. The position will be based in Raritan or Titusville NJ, Spring House PA, High Wycombe UK, Beerse BE or Leiden NL but consideration will be given to other locations. This position requires minimal travel of 5% or less.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Associate, Global Labeling Compliance supports the monitoring of the end-to-end global labeling process and provision of reports and metrics to key stakeholders for implementation of labeling changes. This position works with cross-functional stakeholders in relation to the end-to-end labeling process and audit/inspection readiness for Global Labeling Centre of Excellence (GL CoE) and local operating companies (LOCs).
The Senior Associate, Global Labeling Compliance will be responsible for:
Reporting to an Associate Director and working with limited supervision, this position works as a member of several teams and mentors/trains associates, as needed.
Collaborates with colleagues, management, and relevant stakeholders to make recommendations and decisions that impact the accuracy and timeliness of internal processes, policies, and implementation of labeling changes.
Makes recommendations and decisions with limited supervision and as a member of a team. This position gathers data and performs analyses for decisions.
Gathers and collates data and supports the analysis of overall audit and inspection preparedness. Provides high-quality reports and information, as requested, to support the audit and inspection process.
Gathers information and performs analyses for the reporting of end-to-end labeling process compliance.
Gathers metrics and measurements in support of GL CoE productivity and efficiency.
Generates labeling-related data to the Pharmacovigilance System Master File (PSMF).
Supports the training of relevant stakeholders on the end-to-end global labeling process.
Participates and/or facilitates the review and implementation of GL CoE procedural documents and training.
Tracks timely completion of labeling-related CAPAs and associated effectiveness checks within the GL CoE.
In-depth knowledge of change control requirements and standard document development and training practices.
Familiarity with global labeling regulations and their impact on tracking of timely implementation of labeling changes.
University degree (e.g., Bachelor’s degree), preferably in a Scientific or related or business discipline is required.
4+ years of relevant experience (including 2+ years of pharmaceutical or health care industry experience) is required.
Experience associated with product labeling, labeling regulations and packaging is required.
Experience in delivery of quality procedural documents or appropriate equivalent departmental standards is desired.
Experience with relevant labeling related regulatory requirements is required.
An understanding of the end-to-end global labeling processes is required.
Experience in data analyses and interpretation is required.
Awareness of process excellence, process improvement methodology is desired.
Experience working in teams to achieve shared goals in a time sensitive environment is required.
About Janssen Research & Development, a member of Johnson & Johnson's Family of Companies
Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make... every day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives.