Submission Program Management Leader (SPML)

Johnson and Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a Submission Program Management Leader (SPML) in Raritan, NJ; Titusville, NJ; Horsham, PA; High Wycombe (UK); Leiden (Netherlands); Beerse (Belgium); Allschwil (Switzerland).

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.

Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.

Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

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...