At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Project/Program Management Group **Job Sub** **Function:** R&D Project Management **Job Category:** People Leader **All Job Posting Locations:** Allschwil, Switzerland, BE009 Turnhoutseweg 30, CH024 ACT Allschwil, Switzerland, GB006 High Wycombe, Mechelen, Antwerp, Belgium, NL021 Leiden Emmy Noetherweg, NL022 Leiden Sylviusweg **Job Description:** **About Innovative Medicine** 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. Learn more at https://www.jnj.com/innovative-medicine Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: 2506236560W Remote work options may be considered on a case-by-case basis and if approved by the Company. **We are searching for the best talent for Director, Submission Program Management (SPM) Strategic Partnerships and Process Optimization to be in** **Raritan, NJ; Titusville, NJ; Horsham, PA; High Wycombe (UK); Leiden (Netherlands); Beerse (Belgium); Allschwil (Switzerland)** **Purpose:** The Director, Submission Program Management (SPM) Strategic Partnerships and Process Optimization plays a critical role in shaping the Submission Excellence (SubX) framework and driving continuous improvement in regulatory submission program management (SPM). This role is designed to evolve alongside the organization’s regulatory submission needs, ensuring that submission excellence remains dynamic and continuously optimized. As a strategic thought partner to the Head of SPM, this individual will oversee the development and integration of new technologies, process improvements, and performance metrics while fostering cross-functional collaborations. Additionally, they will engage with internal and external stakeholders to identify and implement SPM and SubX solutions, ensuring organizational sponsorship for key initiatives. The Director will also act as the overall submission process owner, maintaining MS Project templates, translating improvements into submission planning tools, and overseeing the development and execution of training programs to upskill teams. This matrixed leadership role requires both strategic and operational expertise to navigate the complexities of regulatory submissions, ensuring that the organization remains agile and forward-looking. The Director will play a pivotal role in advocating for process enhancements, assessing new system implementations, and driving change management initiatives that will shape the future of submission excellence. **You will be responsible for** **:** + Serve as a strategic thought partner for the SPM Team/SubX Leader in shaping the SubX framework, particularly in coordinating organizational Functional Project Management roles (RPM, CPP, CPM, PDPM) to support new ways of working for submissions. + Identify opportunities and support the development and implementation of new technologies (such as MSP Online, URP, and digital transformation) to enhance submission capabilities. + Ensure the development and tracking of Goals and Objectives (G&Os) for the optimization of the SubX framework, establishing and monitoring Key Performance Indicators (KPIs) to ensure targets are met, and intervening as necessary. + Develop and nurture relationships with internal and external partners to identify key optimization opportunities, securing organizational sponsorship to effectively implement SPM solutions. + Act as the overall Submission Process Owner, including MSP Template ownership + Serve as the primary point of contact for communicating and coordinating the end-to-end submission process, translating cross-functional processes and improvements into the SPML Submission Foundation Plan and the 3-Month Starting Point Plan in collaboration with functional leads and project management teams. + Oversee the development and revisions of the SubX/SPM Training Modules, ensuring version control and maintaining up-to-date training materials. + Conduct training sessions for the SPM team and communicate any revisions made to training content. **Qualifications / Requirements:** + 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 10 years of industry/business experience is required. + A minimum of 8 years of experience leading cross-functional teams in a matrixed work environment is required. + A minimum of 5 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 5 years of formal project management experience with high proficiency and demonstrated application of project management standards, planning and visualization methods/tools is required. + Prior major submission cross-functional leadership experience is strongly preferred + Proven experience in project management, preferably in a pharmaceutical or healthcare environment. Professional Certification in Project Management is preferred. + Strong ability to build and maintain relationships with diverse stakeholders. + Excellent organizational skills and attention to detail. + Proficiency in project management tools and methodologies, including MSP. + Strong communication and presentation skills. + Ability to adapt and thrive in a fast-paced, dynamic environment.