Johnson & Johnson Innovative Medicine
Associate Director, Submission Program Management Lead
Johnson & Johnson Innovative Medicine, Raritan, New Jersey, us, 08869
Overview
Associate Director, Submission Program Management Lead at Johnson & Johnson Innovative Medicine. This role will be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; Leiden, Netherlands; Allschwil, Switzerland; or High Wycombe, United Kingdom. The role focuses on end-to-end operational delivery of major marketing submissions for JJIM, leading global cross-functional submission teams in EU and U.S. markets, and partnering with senior leaders to drive timely NDA/BLA/MAA submissions. Context: Our work accelerates health breakthroughs, guided by the Johnson & Johnson Credo. This role may be posted under different requisition numbers to comply with local requirements. Applications across postings are accepted as a single submission. Note: Availability across multiple countries means postings may differ by requisition number. Purpose
The Submission Program Management Leader (SPML) will be accountable for the end-to-end operational delivery of major marketing submissions for JJIM. The SPML leads global, cross-functional submission teams to meet or exceed operational delivery goals and serves as the primary interface to the Compound Development Team (CDT) regarding operational submission strategy. The SPML partners with the Global Regulatory Leader (GRL), CDT Leader (CDTL), and Project Management Leader (PML) to drive timely delivery of major NDA/BLA/MAA submissions. Key focus areas include ensuring alignment of submission strategy, driving end-to-end operational planning, and delivering a credible, integrated submission plan aligned with target labels and regulatory strategy. Responsibilities
Engage business and team leaders before deploying the Submission Delivery Framework to confirm robust source documentation (Draft Target Label, Target Product Profile, Compound Development Plan, Regulatory Strategy Plan) and team readiness. Collaborate with GRL, CDT, and functional leaders to develop and align submission strategy and scope, achieving alignment on the Submission North Star with Senior Leadership. Lead planning and execution of the Submission Kick-off meeting with key partners and core team members post strategy alignment. Manage cross-functional Submission Working Groups (SWG), driving day-to-day operational decisions and ensuring clarity, commitment, and accountability to the aligned submission strategy across the team and TA leadership. Align messaging and data pooling/incorporation strategies; lead impact assessment of messaging changes. Facilitate strategic discussions with key partners and Senior Leadership focused on prioritization and decision-making around scope, messaging, and data analysis. Translate submission strategy into an integrated submission plan (ISP) with a credible critical path, working with team and functional PMs to ensure cross-functional execution. Define and communicate roles, responsibilities, and accountabilities; incorporate proven methods, functional input, and team commitment to delivery timing and quality when developing the ISP. Oversee detailed planning for Module 2 components (focus on clinical 2.5, 2.7) and critical path Module 1 components (Label, Risk Management), ensuring integration of key milestones into ISP. Maintain and communicate the execution-level critical path; perform ongoing analysis to identify opportunities to de-risk, accelerate, and improve on-time submission delivery. Lead ongoing risk management, including identification, quantification, and communication of risks; develop mitigation plans with clearly defined triggers and owners; conduct scenario analyses and contingency planning; escalate risks to CDT and Senior Leadership as required. Collaborate with Project Management and functional team members on plan and scenario-based modeling to inform decisions. Promote a high-performing, people-centric team culture; empower teams to make rapid, informed decisions and drive innovation. Provide robust, transparent communications throughout the submission process, including progress, priorities, and submission health, and lead submission-specific status updates to SWG, CDT, partners, and governance bodies as needed. Assess and communicate submission team health, including operational metrics to drive action. Work across functions to establish processes and new methods that improve delivery. Education, Qualifications & Requirements
Bachelor's degree required; preferred in Life Sciences, Business Management, Regulatory Affairs or related field. Advanced degree preferred. 8+ years of industry/business experience; 5+ years leading cross-functional teams in a matrix environment; 3+ years in Pharmaceutical, MedTech, or related R&D with end-to-end development knowledge. 3+ years of formal project management experience with proficiency in PM standards, planning, and visualization tools. Proven experience leading cross-functional submission teams through delivery of major marketing applications in U.S. and/or EU; experience with external partners desired. Strong ability to conduct business process, scenario, and critical path analyses on complex, accelerated timelines; solid understanding of interdependencies among eCTD documents. Experience leading sections of Module 2, Module 5, and Module 1 (Label and Risk) in clinical development submissions. Knowledge of global regulatory regulations, timelines, guidelines, and requirements for U.S. and EU marketing applications. Excellent verbal and written communication skills; strong innovative and critical thinking; effective cross-cultural communication; ability to influence without formal authority; ability to translate strategy into actionable plans. Willingness to travel up to 10% (domestic and international). Preferred
Project management certification preferred; regulatory certification (RAC) preferred. Proficiency with Microsoft Project is highly preferred. Other
Up to 10% travel – Domestic & International. Compensation & Benefits
The expected base pay range is $137,000 to $235,750. The Company offers competitive, performance-based compensation, including eligibility for an annual cash bonus. Benefits include medical, dental, vision, life insurance, disability, and other plans; retirement and time-off benefits as described in corporate policies. Specific benefits may vary by location. This posting is anticipated to close on 09/26/2025. The Company may extend this period and keep posting open to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by law. Applicants with disabilities may request accommodations via the Careers site. Additional Information
All postings and references reflect current opportunities; related postings may exist for different locations. For general information on company benefits, see the official careers site: https://www.careers.jnj.com/employee-benefits
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Associate Director, Submission Program Management Lead at Johnson & Johnson Innovative Medicine. This role will be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; Leiden, Netherlands; Allschwil, Switzerland; or High Wycombe, United Kingdom. The role focuses on end-to-end operational delivery of major marketing submissions for JJIM, leading global cross-functional submission teams in EU and U.S. markets, and partnering with senior leaders to drive timely NDA/BLA/MAA submissions. Context: Our work accelerates health breakthroughs, guided by the Johnson & Johnson Credo. This role may be posted under different requisition numbers to comply with local requirements. Applications across postings are accepted as a single submission. Note: Availability across multiple countries means postings may differ by requisition number. Purpose
The Submission Program Management Leader (SPML) will be accountable for the end-to-end operational delivery of major marketing submissions for JJIM. The SPML leads global, cross-functional submission teams to meet or exceed operational delivery goals and serves as the primary interface to the Compound Development Team (CDT) regarding operational submission strategy. The SPML partners with the Global Regulatory Leader (GRL), CDT Leader (CDTL), and Project Management Leader (PML) to drive timely delivery of major NDA/BLA/MAA submissions. Key focus areas include ensuring alignment of submission strategy, driving end-to-end operational planning, and delivering a credible, integrated submission plan aligned with target labels and regulatory strategy. Responsibilities
Engage business and team leaders before deploying the Submission Delivery Framework to confirm robust source documentation (Draft Target Label, Target Product Profile, Compound Development Plan, Regulatory Strategy Plan) and team readiness. Collaborate with GRL, CDT, and functional leaders to develop and align submission strategy and scope, achieving alignment on the Submission North Star with Senior Leadership. Lead planning and execution of the Submission Kick-off meeting with key partners and core team members post strategy alignment. Manage cross-functional Submission Working Groups (SWG), driving day-to-day operational decisions and ensuring clarity, commitment, and accountability to the aligned submission strategy across the team and TA leadership. Align messaging and data pooling/incorporation strategies; lead impact assessment of messaging changes. Facilitate strategic discussions with key partners and Senior Leadership focused on prioritization and decision-making around scope, messaging, and data analysis. Translate submission strategy into an integrated submission plan (ISP) with a credible critical path, working with team and functional PMs to ensure cross-functional execution. Define and communicate roles, responsibilities, and accountabilities; incorporate proven methods, functional input, and team commitment to delivery timing and quality when developing the ISP. Oversee detailed planning for Module 2 components (focus on clinical 2.5, 2.7) and critical path Module 1 components (Label, Risk Management), ensuring integration of key milestones into ISP. Maintain and communicate the execution-level critical path; perform ongoing analysis to identify opportunities to de-risk, accelerate, and improve on-time submission delivery. Lead ongoing risk management, including identification, quantification, and communication of risks; develop mitigation plans with clearly defined triggers and owners; conduct scenario analyses and contingency planning; escalate risks to CDT and Senior Leadership as required. Collaborate with Project Management and functional team members on plan and scenario-based modeling to inform decisions. Promote a high-performing, people-centric team culture; empower teams to make rapid, informed decisions and drive innovation. Provide robust, transparent communications throughout the submission process, including progress, priorities, and submission health, and lead submission-specific status updates to SWG, CDT, partners, and governance bodies as needed. Assess and communicate submission team health, including operational metrics to drive action. Work across functions to establish processes and new methods that improve delivery. Education, Qualifications & Requirements
Bachelor's degree required; preferred in Life Sciences, Business Management, Regulatory Affairs or related field. Advanced degree preferred. 8+ years of industry/business experience; 5+ years leading cross-functional teams in a matrix environment; 3+ years in Pharmaceutical, MedTech, or related R&D with end-to-end development knowledge. 3+ years of formal project management experience with proficiency in PM standards, planning, and visualization tools. Proven experience leading cross-functional submission teams through delivery of major marketing applications in U.S. and/or EU; experience with external partners desired. Strong ability to conduct business process, scenario, and critical path analyses on complex, accelerated timelines; solid understanding of interdependencies among eCTD documents. Experience leading sections of Module 2, Module 5, and Module 1 (Label and Risk) in clinical development submissions. Knowledge of global regulatory regulations, timelines, guidelines, and requirements for U.S. and EU marketing applications. Excellent verbal and written communication skills; strong innovative and critical thinking; effective cross-cultural communication; ability to influence without formal authority; ability to translate strategy into actionable plans. Willingness to travel up to 10% (domestic and international). Preferred
Project management certification preferred; regulatory certification (RAC) preferred. Proficiency with Microsoft Project is highly preferred. Other
Up to 10% travel – Domestic & International. Compensation & Benefits
The expected base pay range is $137,000 to $235,750. The Company offers competitive, performance-based compensation, including eligibility for an annual cash bonus. Benefits include medical, dental, vision, life insurance, disability, and other plans; retirement and time-off benefits as described in corporate policies. Specific benefits may vary by location. This posting is anticipated to close on 09/26/2025. The Company may extend this period and keep posting open to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by law. Applicants with disabilities may request accommodations via the Careers site. Additional Information
All postings and references reflect current opportunities; related postings may exist for different locations. For general information on company benefits, see the official careers site: https://www.careers.jnj.com/employee-benefits
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