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Manager, Global Labeling Compliance
Requisition ID: 00001C2A
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is currently recruiting for a Manager, Global Labeling Compliance to be based in any North America facility, High Wycombe UK, Beerse BE or Leiden NL.
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 Manager, Global Labeling Compliance is responsible for global active monitoring, oversight, and continuous improvement of the end-to-end labeling process, including provision of reports and metrics to key stakeholders to drive timely implementation of labeling changes. This position partners with various Quality organizations to ensure labeling-related audit and inspection readiness for local operating companies (LOCs) and the Global Labeling Centre of Excellence (GL CoE). This role manages the event and deviation process in accordance with Company procedures. The manager ensures compliant, timely documentation and contributes to resolution of escalated issues.
Impact (Outcomes) of Decision-Making: The Manager independently makes recommendations and decisions that drive continuous improvement of labeling-related policies, processes, standards, and global technology systems. This position makes recommendations and decisions that impact timely and compliant implementation of labeling changes.
Accountability/Decision-Making: The Manager ensures appropriate escalation of issues related to delayed implementation of labeling changes, using a systematic approach to solving problems. This position identifies and understands complex problems and recommends common, effective, compliant solutions within a global organization. This role makes recommendations and decisions independently and as a member of a team.
- In-depth knowledge of change control processes, document management, and training processes.
- Working knowledge of global labeling guidance and regional/regulatory requirements, internal standards, polices, and procedures.
- Strong interpersonal, verbal and written communication skills.
- Understanding and experience in the delivery of quality procedural documents or appropriate equivalent departmental standards.
- Ability to use business systems that support labeling processes, including but not limited to document management, change control, event tracking, and artwork management.
- Knowledge of designing training and business aids to support business tools and processes.
- Understanding of complex labeling issues and the ability to translate them into required documentation in accordance with Company procedures (e.g., event, deviation, escalation, CAPA and effectiveness checks).
- Analyzes inspection and audit observations related to labeling to identify areas of improvement for end-to-end global labeling process.
- Manages active monitoring of the end-to-end global labeling process, including assurance of alignment with global regulatory requirements, standards and timelines related to labeling content and implementation.
- Generates and presents metrics and measurements of GL CoE deliverables and productivity.
- Ensures provision of labeling-related data to the Pharmacovigilance System Master File (PSMF) as required by relevant procedures.
- Ensures 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.
- Ensures timely completion of labeling-related CAPAs and associated effectiveness checks within the GL CoE.
- Partners with GL CoE staff to ensure support for the GL CoE during audits and inspections and the management of labeling CAPAs.
- Contributes to support for LOCs during audits and inspections, as needed. Partners with various quality organizations and Regional RA for management and documentation of labeling-related issues via event, deviation, escalation, etc.
- Liaises and partners with key stakeholders to ensure the end-to-end global labeling process is maintained and/or improved. Manages or leads labeling-related improvement projects of moderate size, complexity, and business impact. Executes and drives continuous improvement related to compliance reporting on the end-to-end labeling process to ensure that labeling changes are implemented in a timely manner or escalated as appropriate.
- Participates in review of emerging new labeling guidance and guidance changes; ensures consistent implementation via procedure changes, as needed.
- Provides guidance for local labeling process, including alignment with global process, where applicable.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
- University degree (e.g., Bachelor’s degree), preferably in a scientific or related or business discipline is required an Advanced degree is desired.
- 8+ years of relevant experience required (including 5+ years of pharmaceutical or health care industry experience).
- Experience associated with product labeling/labeling regulations/packaging.
- Experience in delivery of quality procedural documents or appropriate equivalent departmental standards.
- Experience with relevant labeling related regulatory requirements.
- An understanding of the end-to-end global labeling processes.
- Strong verbal and written communication, negotiation and partnering skills.
- Experience in developing and designing data analyses methodology, interpretation and data visualization.
- Experience with process excellence, process improvement methodologies, including change management practices.
- Experience managing external service providers preferred.
- Experience leading a team within a matrix environment to achieve shared goals in a time sensitive environment.
This position will be based in any North America facility, High Wycombe UK, Beerse BE or Leiden NL and will require up to 10% domestic and international travel.
United States-New Jersey-Titusville
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)