Director, Submission Excellence Technology Business Leader

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 ;br>
Job Function:
Project/Program Management Group

Job Sub Function:
R&D Project Management

Job Category:
People Leader

All Job Posting Locations:
Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, South Holland, Netherlands, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

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

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

Switzerland - Requisition Number: R-057946

United Kingdom - Requisition Number: R-057943

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.

The expected base pay range for this position is $164,000 to $282,900.

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.

• Subject to the terms of their respective plans, employees and/or eligible dependents are 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.
• Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company's long-term
  incentive program.
• Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:
  • Vacation -120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
  • Holiday pay, including Floating Holidays -13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
  • Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
  • Caregiver Leave - 10 days
  • Volunteer Leave - 4 days
  • Military Spouse Time-Off - 80 hours

Additional information can be found through the link below.

For additional general information on Company benefits, please go to:

• ;/li>

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.

This job posting is anticipated to close on 02/20/2026. The Company may, however, extend this time-period, in which case the posting will remain available on to accept additional applications.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:
Business Savvy, Consulting, Customer Alignment, Data Analysis, Developing Others, Inclusive Leadership, Information Technology Strategies, Leadership, Process Improvements, Product Portfolio Management, Project Management Methodology (PMM), Project Management Office (PMO), Quality Standards, Risk Assessments, Strategic Thinking, Succession Planning, Training People

The anticipated base pay range for this position is :
$164,000.00 - $282,900.00

Additional Description for Pay Transparency: