Director, Risk Management Scientific Lead (RMSL)

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Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies, is recruiting for a Director, Risk Management Scientific Lead (RMSL) to be based in Raritan, NJ, Titusville, NJ, Horsham, PA, High Wycombe, Great Britain OR Beerse, Belgium. Remote in the US or Europe may also be considered. Janssen R&D discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases & vaccines, cardiovascular and metabolic diseases. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. The Risk Management Scientific Lead (RMSL) is responsible for providing strategic risk management support for Janssen Pharma products. The position is part of the Global Safety Strategy and Risk Management (GSSRM) group in Global Medical Safety and reports to the Head, Risk Management Scientists. The RMSL provides strategic support across the Janssen Pharma organization for projects related to safety risk management, including Core Risk Management Plans (RMPs), European Union Risk Management Plans (EU-RMPs), local RMPs/local addenda (as applicable), and Risk Evaluation and Mitigation Strategies (REMS). These activities are accomplished in close collaboration with the Medical Safety Officer (MSO), members of the respective product Safety Management Team (SMT), Regulatory Medical Writing, and Local Safety Officers (LSOs). The RMSL also supports the EU Qualified Person for Pharmacovigilance (QPPV) Pharma in maintaining oversight of the benefit-risk profiles of Janssen Pharma products. The RMSL is responsible for ensuring a consistent approach to safety risk management across the Janssen Pharma portfolio, as well as compliance with Company policies and procedures and global pharmacovigilance (PV) regulations. The RMSL helps to ensure a harmonized, global approach to benefit-risk decision making, thereby assisting teams in making informed product-specific safety risk management decisions. As a Company expert on global risk management, the RMSL participates as a member of or leads cross-functional teams to develop and promote best practices, processes, and tools to: Promote consistent safety risk management excellence across Janssen Pharma Ensure safe and appropriate use of Janssen Pharma products, and Drive continuous process improvements related to safety risk management. Primary Responsibilities Include: Partner with the MSOs and LSOs to provide strategic guidance to product teams during the development of risk management planning documents, provide recommendations for risk management activities including country-specific PV and risk minimization activities, and participate in SMT and LOC meetings in support of risk management activities, as needed Provide support to the MSOs and SMTs with regard to the development of Company Core Risk Management Documentation Sheets (CCRMDSs) Attend planning, kick-off, and other relevant safety risk management meetings during the document development cycle Perform strategic, targeted review of risk management planning documents for appropriateness of content, compliance with applicable template(s), and consistency with related documents (eg, product labeling, assessment reports, requests for supplemental information) Develop and promote best practices, processes, tools, and policies to ensure consistent safety risk management excellence across the organization Provide information and training across the organization Maintain and share knowledge of evolving global regulatory risk management requirements As appropriate, lead or participate in the provision of feedback regarding draft guidances and other regulatory initiatives to health authorities As appropriate, partner with other functional areas to support safety risk management initiatives Identify, explore, and pursue innovative risk management opportunities through internal and external partnerships Proactively identify and resolve issues related to safety risk management Ensure that risk management documents are compliant with relevant regulatory requirements Qualifications Education: PharmD OR PhD is highly preferred. Minimum of a Masters’ Degree is required. Experience: 5 years of pharmaceutical industry experience with at least 3 years of experience in PV is required. Experience in the evaluation of clinical and post marketing safety data is required. Demonstrated excellence in scientific analysis and presentation is required. Good understanding of global PV regulations is preferred. Ability to effectively interact with external stakeholders, including business partners is preferred Ability to manage/lead in a matrix environment is required Subject matter expertise helpful to succeed in this role: Knowledge of global regulatory framework for risk management is preferred Experience in developing risk management strategies and/or risk management-related documents is preferred. Excellent verbal and written communication skills is required Proven leadership skills is required Ability to plan work to meet deadlines and effectively handle multiple priorities is required. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Pennsylvania-Horsham-800/850 Ridgeview Drive Other Locations Europe/Middle East/Africa, North America-United States, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105959063W