Associate Director, Submission Program Management Lead (1 of 6) - 2306158967W

　　Description

　　Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Submission Program Management Lead. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium or Leiden, Netherlands. Remote work options may be considered on a case-by-case basis and if approved by the company.

　　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. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

　　Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

　　The Associate Director, Submission Program Management Lead (SPML) will be accountable for the end-to-end operational delivery of major marketing submissions for Johnson & Johnson Innovative Medicine (JJIM). The Associate Director, SPML will be responsible for leading global, cross-functional submission teams to meet or exceed the operational delivery goals for JJIM’s major submissions in EU and U.S. markets and is the primary interface to JJIM’s Compound Development Team (CDT) regarding operational submission strategy. The individual will be a key partner to the Global Regulatory Leader (GRL), Compound Development Team Leader (CDTL) and Project Management Leader (PML) in driving the timely delivery of major NDA/BLA/MAA submissions. Work across teams at all levels of the organization to ensure the highest probability of successful submission delivery while enhancing team empowerment, effectiveness, and efficiency in accordance with the Johnson & Johnson Credo. This includes:

　　Close partnership with the CDT, Therapeutic Area (TA) and Functional Leadership, working hand in hand with the GRL to facilitate alignment, clarity, understanding and endorsement of the overall submission strategy or submission “North Star” based on target label and overall global regulatory strategy.

　　Driving development of the end-to-end operational submission strategy in alignment with overall submission strategy and goals, ensuring alignment and commitment from functional leaders and team members.

　　Oversight of operations/delivery process, leading the cross-functional submission workgroup(s) and partnering with responsible functional project managers and team members to drive planning, optimization, and execution.

　　Close partnership with team and functional leaders to ensure adherence to best practices, proper risk mitigation and delivery enhancement strategies to provide the team with the highest probability of operational success in submission delivery.

　　This role may support submissions in any of the following TAs: Immunology, Oncology, Neuroscience, Pulmonary Hypertension, Infectious Disease, Cardiovascular and Metabolism.

　　Principal Responsibilities:

　　Engage business and team leaders in advance of full deployment of the Submission Delivery Framework to confirm availability and alignment of robust source documentation (Draft Target Label, Target Product Profile, Compound Development Plan, and Regulatory Strategy Plan), raising awareness and team readiness as required.

　　In partnership with the GRL, collaborate with CDT and functional leaders to develop and align on submission strategy and scope and gain alignment on Submission North Star with Senior Leadership.

　　Lead planning and execution of the Submission Kick-off meeting partnering with key stakeholders and core team members at the ideal timeframe post strategy alignment.

　　Lead cross-functional Submission Working Group (SWG), driving day-to-day operational decision-making and ensuring clarity, commitment and accountability of team to aligned submission strategy throughout execution at all levels of the submission team and TA Leadership.

　　Ensure team alignment to overall key messaging and data pooling/incorporation strategies, and lead teams in impact assessment of messaging changes.

　　Facilitate strategic discussions in collaboration with Key Stakeholders and Senior Leadership that are grounded in “Label as Driver” thinking as a holistic view of success and approvability to ensure proper prioritization and decision-making around operational activities, ad hoc changes to scope, messaging, and data analysis.

　　Lead translation of submission strategy and scope into integrated submission plan (ISP) working with team and functional project managers to ensure aligned, cross-functional, integrated execution level plan with a credible critical path.

　　When developing ISP, ensure proper assignment and clarity in roles, responsibilities, and accountabilities, incorporation of all applicable organizational best practices, functional area input, and team commitment to delivery timing and quality.

　　Own detailed planning and execution oversight for Module 2 components (focus on clinical 2.5, 2.7), critical path Module 1 components (Label, Risk Management), partnering with functional PMs to ensure integration of all key/critical milestones/planning on or near critical path (e.g., LPO, DBL, TLR/TLG, CSR, Non-Clinical, CMC) into ISP.

　　Maintain and communicate execution level critical path throughout submission delivery and perform ongoing critical path analysis to continuously drive efforts to uncover and exploit new opportunities to de-risk, accelerate, and increase overall probability of on time submission delivery.

　　Lead ongoing risk management efforts including:

　　o Identification, quantification, and transparency to areas of risk/uncertainty impacting the schedule and overall probability of timely submission.

　　o Ensure robust risk mitigation plans are in place for all “impactful” risks to the ISP including clearly defined risk triggers and owners.

　　o Lead scenario analysis/contingency planning for the overall submission including ongoing opportunity, risk and recovery (issue) analysis.

　　o Communicate mitigation strategies and escalation of overall submission-related risks to CDT and Senior Leadership, as required.

　　Collaborate with Project Management and functional team members to perform plan and scenario-based modeling to enhance team decisions and actions.

　　Promote a high-performing, people-centric team culture, empowering teams to drive rapid and informed decision making, challenge status quo, and foster impactful innovation.

　　Provide robust, customized, and transparent communications throughout the submission process to various audiences:

　　o Ensure ongoing visibility to progress, priorities, and submission “health” according to ISP and defined submission goals.

　　o Lead submission-specific status communications to the SWG, CDT, Key Stakeholders, and other Management Reviews, as required.

　　Lead ongoing assessment and communication of submission team health, including operational metrics to measure performance and drive meaningful action.

　　Work across functions and organizational boundaries, engaging directly with TA and functional leaders to establish processes, procedures, and new innovative methods that improve overall delivery.

　　Contribute to the strategy and development of department capability.

　　Qualifications

　　A minimum of a Bachelor’s degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related discipline. Advanced degree preferred.

　　A minimum of 7 years of industry/business experience is required.

　　A minimum of 5 years of experience leading cross-functional teams in a matrixed work environment is required.

　　A minimum of 3 years of experience in a Pharmaceutical, MedTech or comparable R&D area with demonstrated organizational awareness and applied knowledge of end-to-end (E2E) drug or medical device development is required.

　　A minimum of 3 years of formal project management experience with proficiency and demonstrated application of project management standards, planning and visualization methods/tools is required.

　　Demonstrated project management leadership of cross-functional submission teams through delivery of major marketing applications in U.S. and/or EU in a matrixed setting, including working with external partners, is required.

　　Experience conducting business process, scenario, and critical path analysis on complex projects with accelerated timelines is required.

　　Demonstrated strong “content awareness” and understanding of interdependencies between all major documents of eCTD is required.

　　Experience leading teams through delivery of clinically focused sections of Module 2, Module 5, and Module 1 label and risk sections is required.

　　Knowledge of global regulations, regulatory timelines, guidelines, and regulatory requirements related to marketing application in the U.S. and EU is required.

　　Project management certification preferred.

　　Regulatory certification (RAC) preferred.

　　Proficiency with Microsoft Project is highly preferred.

　　Must have excellent verbal and written communication skills.

　　Must have strong innovative and strategic thinking skills.

　　Must have effective cross-cultural communication skills with the ability to motivate and inspire a team to action.

　　Experience driving and expediting team decision-making and translating strategy to clear, executable action plans is required.

　　Experience resolving controversy and influencing teams without formal authority is required.

　　Experience influencing decision-making at all levels and representing project teams with senior leadership and governance bodies is required.

　　This position will require up to 10% domestic and international travel.

　　The anticipated base pay range for this position in the San Francisco Bay Area, CA is $166,000 to $267,145.

　　The anticipated base pay range for this position in all other U.S. locations is $135,000 to $232,300.

　　The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

　　Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

　　Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

　　Employees are eligible for the following time off benefits:

　　Vacation - up to 120 hours per calendar year

　　Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

　　Holiday pay, including Floating Holidays - up to 13 days per calendar year

　　Work, Personal and Family Time - up to 40 hours per calendar year

　　For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

　　The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.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 NA-US-Pennsylvania-Spring House

　　Other Locations NA-United States, NA-US-Pennsylvania-Horsham, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, NA-US-New Jersey-Raritan, NA-US-New Jersey-Titusville

　　Organization Janssen Research & Development, LLC (6084)

　　Relocation Eligible: Yes - Within Country

　　Job Function Regulatory Product Submissions and Registration

　　Req ID: 2306158967W