Director, Process Optimization Lead (Unified Regulatory Platform)

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:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Cambridge, Massachusetts, United States of America, Raritan, 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

We are searching for the best talent for a Director, Process Optimization Lead (Unified Regulatory Platform) to be located in Raritan, NJ or Cambridge, MA.

  
 

Purpose:
The Director, Process Optimization Lead (Unified Regulatory Platform) is responsible for driving an effective model for the development of E2E processes which connect across GRA capabilities for the establishment and advancement of the new URP platform.

This role will focus on identifying opportunities for streamlining and standardizing regulatory processes, reducing cycle times, and improving overall efficiency.

This role will take part in driving the definition and implementation of an E2E process management model across GRA capabilities, which is compatible and aligned with business data and technology solutions. 

 

You will be responsible for:



* Develop and implement a global regulatory process strategy that aligns with overall business objectives.


* Take part in driving the definition and implementation of an E2E process management model, including connectivity with partner organizations for shared process ownership (e.g., Clinical, Safety, Supply Chain), and reach alignment with key stakeholders on implementation.  


* Apply consistent process design methodologies/frameworks (e.g., six sigma, Lean, BPM) to identify opportunities for streamlining/standardizing regulatory processes, reducing cycle times, improving overall efficiency, and helping to align overlapping sub-processes across workflows.


* Take part in driving timely formation of URP project teams with appropriate leadership, skillsets, and resources (internal and external as required) to deliver future state E2E processes per capability.

Escalate and resolve issu...