Talent.com
No longer accepting applications
Associate Director, Submission Program Management Lead

Associate Director, Submission Program Management Lead

J&J Family of CompaniesSpring House, PA, US
14 days ago
Job type
  • Full-time
Job description

Associate Director, Submission Program Management Lead

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for an Associate Director, Submission Program Management Lead to be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; Leiden, Netherlands; Allschwil, Switzerland or High Wycombe, United Kingdom.

Purpose : The Submission Program Management Leader (SPML) will be accountable for the end-to-end operational delivery of major marketing submissions for Johnson & Johnson Innovative Medicine (JJIM). The 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 SPML 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.

This individual will 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 leading practices, proper risk mitigation and delivery enhancement strategies to provide the team with the highest probability of operational success in submission delivery.

You will be responsible for :

  • Engaging 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, collaborating with CDT and functional leaders to develop and align on submission strategy and scope and gain alignment on Submission North Star with Senior Leadership.
  • Leading planning and execution of the Submission Kick-off meeting partnering with key partners and core team members at the optimal timeframe post strategy alignment.
  • Leading 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.
  • Ensuring team alignment to overall key messaging and data strategies, and lead teams in impact assessment of messaging changes.
  • Facilitating strategic discussions in collaboration with key partners and Senior Leadership that are grounded in "Label as Driver" thinking as a complete view of success and approvability to ensure proper prioritization and decision-making around operational activities, ad hoc changes to scope, messaging, and data analysis.
  • Leading 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.
  • Ensuring proper assignment and clarity in roles, responsibilities, and accountabilities, incorporation of all applicable organizational proven methods, functional area input, and team commitment to delivery timing and quality when developing ISP.
  • Owning 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 achievements / planning on or near critical path (e.g., LPO, DBL, TLR / TLG, CSR, Non-Clinical, CMC) into ISP.
  • Maintaining and communicating 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.
  • Leading ongoing risk management efforts including :
  • Identification, quantification, and transparency to areas of risk / uncertainty impacting the schedule and overall probability of timely submission.
  • Ensuring robust risk mitigation plans are in place for all "impactful" risks to the ISP including clearly defined risk triggers and owners.
  • Leading scenario analysis / contingency planning for the overall submission including ongoing opportunity, risk and recovery (issue) analysis.
  • Communicating mitigation strategies and escalation of overall submission-related risks to CDT and Senior Leadership, as required.
  • Collaborating with Project Management and functional team members to perform plan and scenario-based modeling to enhance team decisions and actions.
  • Promoting high-performing, people-centric team culture, empowering teams to drive rapid and informed decision making, challenge status quo, and foster impactful innovation.
  • Providing robust, customized, and transparent communications throughout the submission process to various audiences :
  • Ensuring ongoing insight to progress, priorities, and submission "health" according to ISP and defined submission goals.
  • Leading submission-specific status communications to the SWG, CDT, key partners, and other Management Reviews, as required.
  • Leading ongoing assessment and communication of submission team health, including operational metrics to measure performance and drive meaningful action.
  • Working across functions and organizational boundaries, engaging directly with TA and functional leaders to establish processes, procedures, and new innovative methods that improve overall delivery.

    • Qualifications / Requirements :

    Education :

  • A minimum of a Bachelor's degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related field. An advanced degree is preferred.

    • Experience and Skills :

    Required :

  • 8+ 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.
  • 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 high 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.
  • Proven 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.
  • Must have excellent verbal and written communication skills.
  • Must have strong innovative and critical thinking skills.
  • Must have effective cross-cultural communication skills with the ability to motivate and inspire a team to action.
  • Ability to drive and expedite team decision-making and translate strategy to clear, executable action plans is required.
  • Ability to resolve controversy and influence teams without formal authority is required.
  • Ability to influence decision-making at all levels and represent project teams with senior leadership and governance bodies is required.

    • Preferred :

  • Project management certification preferred.
  • Regulatory certification (RAC) preferred.
  • Proficiency with Microsoft Project is highly preferred.
    • Create a job alert for this search

    Director Program Management • Spring House, PA, US

    Related jobs
    • Promoted
    Associate Director, Program Management (TS / SCI) {S}

    Associate Director, Program Management (TS / SCI) {S}

    Clearance JobsKing Of Prussia, PA, US
    Full-time
    This position is for a Portfolio Manager of our Decision Superiority portfolio.This role requires a strong understanding of Space Mission Management and Orchestration, and Predictive Analytics for ...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director Revenue Cycle

    Associate Director Revenue Cycle

    JobotPhiladelphia, PA, US
    Full-time
    WORK FOR THE TOP HEALTHCARE PROVIDER IN PHILLY!.This Jobot Job is hosted by : Caitlin Pohl.Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary : $80,000...Show moreLast updated: 2 days ago
    • Promoted
    Associate Director

    Associate Director

    Sellers DorseyPhiladelphia, PA, US
    Full-time
    Associate Director Of Accounting.Sellers Dorsey is a healthcare impact strategy firm focused on improving care access, quality, and outcomes for our nation's most vulnerable populations.We work wit...Show moreLast updated: 4 days ago
    • Promoted
    CLINICAL PROGRAM DIRECTOR

    CLINICAL PROGRAM DIRECTOR

    Universal Health ServicesKing Of Prussia, PA, US
    Full-time
    One of the nation's largest and most respected providers of hospital and healthcare services, Universal Health Services, Inc. UHS) has built an impressive record of achievement and performance.Growi...Show moreLast updated: 30+ days ago
    • Promoted
    Program Director

    Program Director

    The Little GymArdmore, PA, US
    Full-time
    Why Is The Little Gym A Great Place To Work?.Fun, high-energy work environment.Comprehensive ongoing career training.Excellent opportunity for career growth and advancement.Company Overview : With m...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Founder Resources, Venture Lab, Wharton School

    Associate Director, Founder Resources, Venture Lab, Wharton School

    Wharton SchoolPhiladelphia, PA, US
    Full-time
    Associate Director, Founder Resources, Venture Lab, Wharton School.Founded in 1881 as the world's first collegiate business school, the Wharton School of the University of Pennsylvania is shaping t...Show moreLast updated: 30+ days ago
    • Promoted
    Program Director

    Program Director

    Community Services GroupBethlehem, PA, US
    Full-time
    It's fun to work in a company where people truly BELIEVE in what they're doing!.We're committed to bringing passion and customer focus to the business. The Program Director provides management, over...Show moreLast updated: 5 days ago
    • Promoted
    Associate Director, Product Source Management

    Associate Director, Product Source Management

    MerckWest Point, PA, US
    Full-time
    Associate Director, Supply Chain Management.Under the direction of the Network Strategy & Execution Director, the Associate Director is responsible for assessing, leading and managing the successfu...Show moreLast updated: 11 days ago
    • Promoted
    Associate Director, Planning System Lead

    Associate Director, Planning System Lead

    J&J Family of CompaniesSpring House, PA, US
    Full-time
    Associate Director, Planning System Lead.Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Planning System Lead. This position is a hybrid role and can be located in...Show moreLast updated: 4 days ago
    • Promoted
    Associate Director, Corporate Alliances (Hybrid)

    Associate Director, Corporate Alliances (Hybrid)

    American Association for Cancer ResearchPhiladelphia, PA, US
    Temporary
    AACR Foundation Associate Director of Corporate Alliances.The American Association for Cancer Research (AACR), with more than 58,000 members residing in 141 countries, is the first and largest orga...Show moreLast updated: 30+ days ago
    • Promoted
    Program Director

    Program Director

    Youth Advocate ProgramsHaddon Heights, NJ, US
    Full-time
    Requisition Number : PROGR002615.Location : Haddon Heights, NJ 08035, USA.Pay Range : $60,000 to $70,000 USD.Summary of Position : Program Director is responsible for the overall administration of the ...Show moreLast updated: 30+ days ago
    Associate Director, Academic Planning and Effectiveness

    Associate Director, Academic Planning and Effectiveness

    Temple UniversityUSA, Pennsylvania, Philadelphia
    Full-time
    Temple University's Tyler School of Art and Architecture is searching for an Associate Director, Academic Planning and Effectiveness!. Become a part of the Temple family and you will have access to ...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Center Operations Director - Market

    Associate Center Operations Director - Market

    ChenMedPhiladelphia, PA, US
    Full-time
    We're changing lives every day.For both our patients and our team members.Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts? Do you inspire others with y...Show moreLast updated: 30+ days ago
    • Promoted
    Program Director

    Program Director

    BancroftMount Laurel, NJ, US
    Full-time
    Bancroft is a leading service-provider for children and adults with autism, other intellectual or developmental disabilities or those in need of neurological rehabilitation.We provide a full contin...Show moreLast updated: 2 days ago
    • Promoted
    Associate Director, Launch Excellence - United States

    Associate Director, Launch Excellence - United States

    MerckWest Point, PA, US
    Full-time
    Associate Director, Launch Excellence.Embark on an exciting journey to transform the US market and be at the forefront of new launches and launch excellence capabilities with our US Strategy and Co...Show moreLast updated: 30+ days ago
    • Promoted
    Program Director

    Program Director

    SevitaMount Laurel, NJ, US
    Full-time +1
    Program Director, Idd Services.Location : Oversees Operations of 3-4 Group Homes in Burlington / Camden / Gloucester Counties. Have you been looking for a fantastic role to continue your career path in S...Show moreLast updated: 23 days ago
    Associate Insights Director

    Associate Insights Director

    SPHERIX GLOBAL INSIGHTS US INCExton, PA, US
    Full-time
    Quick Apply
    Job Description – Associate Insights Director Overview The primary role of the Associate Insights Director is to support and provide disease area expertise to the end-to-end insights generati...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Project Management Capabilities

    Associate Director, Project Management Capabilities

    J&J Family of CompaniesWashington Crossing, PA, US
    Full-time
    Associate Director, Project Management Capabilities.Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Project Management Capabilities. This position is a hybrid role...Show moreLast updated: 10 days ago
    • Promoted
    Director, R&D Program Management

    Director, R&D Program Management

    OrganonLafayette Hill, PA, US
    Full-time
    We are looking for an experienced Director, Program Management (PM) to join our versatile team and center of excellence for portfolio and program management. This successful candidate will have adva...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Client Solutions

    Associate Director, Client Solutions

    InfluentialCamden, NJ, US
    Full-time
    Associate Director, Client Solutions.Influential is a key leader in the Influencer Marketing space and the largest influencer marketing company in the world, by revenue. Trusted by over 60% of the F...Show moreLast updated: 30+ days ago