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 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, 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 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

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.
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• 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