Manager, Global Labeling Compliance Job

Job description

Manager, Global Labeling Compliance-1500058628WDescriptionAt Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson (J&J). Please visithttp://www.janssen.co.uk/ for more information.
Position Title: Manager, Global Labeling ComplianceLocation: The position will be based at any of the following Janssen R&D sites: UK (High Wycombe), Netherlands (Leiden), Belgium (Beerse) or US (Titusville, NJ, Raritan, NJ or Spring House, PA).Travel: 10-15%Closing Date: 2nd October 2015Position summaryAs part of the Global Labeling Centre of Excellence (GL CoE), the Global Labeling Compliance (GLC) function is responsible for end-to-end labeling process ownership, and is focused on ensuring timely implementation of labeling changes across all markets globally. GLC interfaces with a large number of stakeholder groups from across the business units, from Regulatory, to Quality, to Supply Chain, and including Local Operating Companies globally, to establish labeling requirements and standards which contribute to safe and effective use of Janssen products.
This role has responsibility for:
- Active monitoring of end-to-end labeling process and provision of reports and metrics to key stakeholders, to drive timely implementation of labeling changes
- Continuous improvement of the end-to-end labeling process
- Participation in, or leadership of, improvement projects related to labeling
- Partnership with Quality organisations including Global Regulatory Affairs Quality Management (QM), R&D Quality & Compliance, Business Quality (BQ) etc., in relation to end-to-end global labeling process and audit/inspection readiness for Global Labeling Centre of Excellence (GL CoE) and local operating companies (LOCs), including management and documentation of issues via event, deviation, escalation etc.
- Training of relevant staff in the end-to-end labeling process
- Development of GL CoE processes, Standard Operating Procedures, Job Aids and training materialsMetrics & measurements of GL CoE and end-to-end labeling process performanceResponsibilitiesSupport documentation of end-to-end labeling process, including global requirements, standards and timelines related to labeling content and implementation
- Liaise and partner with key stakeholders to ensure the end-to-end labeling process is documented and maintained
- Provide support for local labeling process, including alignment with global process, where possible
- Ensure training of relevant stakeholders on the end-to-end labeling process
- Execute and drive continuous improvement of processes 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.
- Participate in cross-sector discussions regarding labeling process and compliance
- Manage or lead smaller scope improvement projects related to labeling
- Partner with GL CoE staff to ensure support for the GL CoE during audits and inspections and the management of labeling CAPAs
- Ensure that knowledge gained from audits, inspections and CAPAs is incorporated into the standard work of the GL CoE for continuous process improvement
- Ensure timely completion of labeling-related CAPAs and associated effectiveness checks within the GL CoE.
- Contribute to support for LOCs during audits and inspections, as needed
- Partner with GRA QM, R&D Q&C and Regional RA for management and documentation of labeling-related issues via event, deviation, escalation, etc.
- Collate and analyse overall inspection and audit observations related to labeling to identify areas of opportunity and improvement for end-to-end labeling process
- Generate and present metrics & measurements of GL CoE deliverables and productivity
- Generate metrics and measurements of end-to-end labeling process performance
- Participate in review of emerging new labeling guidance and guidance changes; ensure consistent implementation via procedure changes, as neededGenerate and provide labeling-related data to the Pharmacovigilance System Master File (PSMF) as required by relevant proceduresQualificationsKey Skills and Competencies required:
- Regulatory Affairs competencies and proficiency levels may include: Applied Technical Knowledge, Business Acumen, Decision Making and Prioritization, External Focus, Leading and Influencing, and Persuasive Communication
- Understanding of global technical labeling guidance and requirements
- Proven experience in delivery of quality procedural documents or appropriate equivalent departmental standards
- Ability to design training and business aids to support business tools and processes
- Demonstrated ability to use business systems that support labeling processes, including document management, labeling submissions, artwork creation and implementation
- Demonstrated ability to understand complex labeling issues, and translate into required documentation, e.g., event, deviation, escalation, CAPA
- Ability to conceptualize and ensure alignment of business processes and technical systems
- Ability to work in a matrix environment
- Ability to liaise, partner, influence and negotiate with cross functional and cross enterprise departments desiredEducation and Experience required:
- Minimum of Bachelor’s degree in a scientific or related or business discipline required
- Sound experience within a pharmaceutical or health authority environment, including strong experience of Regulatory Affairs including product labeling/labeling regulations/packaging
- Some experience within a supervisory capacity or leading teams within a matrix environment desired
- Exceptional verbal and written communication, negotiation and partnering skills highly desired
- An understanding of the end-to-end labeling process required
- Demonstrated proactive approach and focus on continuous improvement highly desired
- Demonstrated ability to drive collaborative, customer-focused, learning culture highly desired
- Knowledge of process excellence, process improvement, LEAN, highly desiredWhat type of mark will you make?Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world.
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We respectfully request Government Officials to identify themselves as such on application; for the purposes of the Foreign Corrupt Practices ActPrimary Location:Europe/Middle East/Africa-United Kingdom-England-High WycombeOther Locations:North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization: Janssen Cilag Ltd. (7360)Travel:Yes, 10 % of the TimeJob Function: Regulatory AffairsCertain 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.
Johnson and 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. EEO is the Law EEO is the Law GINA Supplement