Associate Director, Submission Program Management Lead

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:

Professional

All Job Posting Locations:

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  

We are searching for the best talent for an Associate Director, Submission Program Management Lead to be located in Spring House, PA; Raritan, NJ or Titusville, NJ.

Purpose: The Submission Program Management Leader (SPML) will be accountable for the end-to-end operational delivery of major marketing submissions for Johnson & Johnson Innovative Medicine (JJIM). The SPML will be responsible for leading global, cross-functional submission teams to meet or exceed the operational delivery goals for JJIM’s major submissions in EU and U.S. markets and is the primary interface to JJIM’s Compound Development Team (CDT) regarding operational submission strategy. The SPML will be a key partner to the Global Regulatory Leader (GRL), Compound Development Team Leader (CDTL) and Project Management Leader (PML) in driving the timely delivery of major NDA/BLA/MAA submissions.

This individual will work across teams at all levels of the organization to ensure the highest probability of successful submission delivery while enhancing team empowerment, effectiveness, and efficiency in accordance with the Johnson & Johnson Credo. This includes:
 

• Close partnership with the CDT, Therapeutic Area (TA) and Functional Leadership, working hand in hand with the GRL to facilitate alignment, clarity, understanding and endorsement of the overall submission strategy or submission “North Star” based on target label and overall global regulatory strategy.
   
• Driving development of the end-to-end operational submission strategy in alignment with overall submission strategy and goals, ensuring alignment and commitment from functional leaders and team members.
   
• Oversight of operations/delivery process, leading the cross-functional submission workgroup(s) and partnering with responsible functional project managers and team members to drive planning, optimization, and execution.
   
• Close partnership with team and functional leaders to ensure adherence to leading practices, proper risk mitigation and delivery enhancement strategies to provide the team with the highest probability of operational success in submission delivery.

You will be responsible for:

• Engaging business and team leaders in advance of full deployment of the Submission Delivery Framework to confirm availability and alignment of robust source documentation (Draft Target Label, Target Product Profile, Compound Development Plan, and Regulatory Strategy Plan), raising awareness and team readiness as required.
   
• In partnership with the GRL, collaborating with CDT and functional leaders to develop and align on submission strategy and scope and gain alignment on Submission North Star with Senior Leadership.
   
• Leading planning and execution of the Submission Kick-off meeting partnering with key partners and core team members at the optimal timeframe post strategy alignment.
   
• Leading cross-functional Submission Working Group (SWG), driving day-to-day operational decision-making and ensuring clarity, commitment, and accountability of team to aligned submission strategy throughout execution at all levels of the submission team and TA Leadership.
   
• Ensuring team alignment