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Associate Director, Submission Program Management Lead

Associate Director, Submission Program Management Lead

J&J Family of CompaniesPortland, ME, US
30+ 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.
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