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):

Belgium; Netherlands - Requisition Number: R-057919

United Kingdom - Requisition Number: R-057943

United States - Requisition Number: R-056297

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for a Director, Submission Excellence Technology Business Leader to be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; Leiden Netherlands; Allschwil, Switzerland or High Wycombe, United Kingdom.

Purpose: The Director, Submission Excellence (SubX) Technology Business Leader will serve as the strategic and operational integrator for the SubX Technology development, partnering with the leadership team and cross-functional teams to plan, coordinate and deliver the multi-year technology roadmap that accelerates regulatory submissions through technology, automation and AI. The role aligns business priorities with platform delivery, coordinates program operations and workstreams, establishes milestones and OKRs, and tracks execution to ensure outcomes are realized.

Acting as a thought partner and the voice of the customer across Global Regulatory Affairs (GRA), Medical Writing, Biostatistics, Regulatory Operations, Data Sciences and Johnson & Johnson Technology (JJT), the leader converts business requirements into clear specifications, oversees project status, resolves risks and interdependencies, and guides change, communications and adoption to embed new ways of working. The leader builds relationships with internal and external partners, manages program-level budgets and vendor engagements, and prepares insights and materials for senior governance discussions. Success is measured by consistent progress against milestones, reduction in submission cycle time, quality and compliance outcomes, and durable adoption of submission tools and capabilities across assets and regions.

You will be responsible for:

• Serving as strategic thought partner to SubX leadership on priorities, roadmap, operating model, and budget; translate strategy into executable plans and quarterly OKRs.
  
• Standing up and running the SubX technology program office: governance cadence, meeting preparation, decision logs, action tracking to closure, and issue/risk management.
  
• Establishing and monitoring progress toward multi-year SubX technology key deliverables; intervening to remove roadblocks and keep critical-path items on track.
  
• Coordinating and consolidating business requirements for submission tools (e.g., biostats automation, document generation, QC/review, regulatory intelligence, publishing) and ensuring they are delivered into solution designs and releases.
  
• Developing integrated, cross-functional plans spanning GRA, Medical Writing, Biostatistics, Regulatory Operations, Data Sciences, and JJT; aligning dependencies with other technology development programs.
  
• Overseeing program portfolio, resources, and budget; supporting build/partner/buy evaluations and vendor management in partnership with Procurement and Finance.
  
• Preparing executive-ready status, dashboards, investment cases, CARs, and leadership presentations; ensuring clear storytelling of value, risks, and decisions.
  
• Leading change management and communications for SubX at the program layer; enabling initiative-level change/communications execution.
  
• Driving process optimization and adoption of new digital workflows; defining success measures and monitor user experience, engagement, and compliance.
  
• Ensuring alignment to standards and policies (e.g., eCTD, CDISC), responsible AI practices, and audit-ready documentation.
  
• Acting as primary liaison to enabling functions (Finance, Procurement) to accelerate resourcing and contracting.
  
• Coaching and developing a high-performing, diverse matrixed team (PMs, change partners, analysts, workstream leads); fostering an agile, learning culture.
  

Qualifications/Requirements:

Education:

• A minimum of a Bachelor's degree in a scientific, technical, IT or business related field is required. An advanced degree is preferred.
  

Experience and Skills:

Required:

• 10+ years of overall work experience, including 6+ years in the pharmaceutical/healthcare industry is required. industry/business experience is required.
  
• A minimum of 6 years in a pharmaceutical/MedTech or comparable R&D area, with demonstrated organizational awareness and applied end-to-end (E2E) drug or medical device development knowledge is required.
  
• A track record leading complex, cross-functional programs and managing multiple workstreams from inception through close-out is required.
  
• Demonstrated ability to build cross-group plans, drive execution, and report progress; strong partner management and executive communication skills is required.
  
• Experience coordinating business requirements into system design/development and releases in partnership with technology teams is required.
  

Preferred:

• Experience in R&D operations or related fields; ability to influence senior leaders and key partners is preferred.
  
• Certifications such as Six Sigma, LEAN, PMP and/or Agile; demonstrated process transformation and culture change leadership is preferred.
  
• Experience with end-to-end process for operationalizing major regulatory submissions is preferred.
  
• Experience with IT system design, development and implementation; vendor/SOW management is preferred.

#LI-Hybrid

Preferred Skills: