Johnson & Johnson Innovative Medicine is recruiting for Expert RA Professional Submissions, Submission Management. The position can be located on-site/hybrid in the US (Titusville, NJ; Spring House, PA; Raritan, NJ) or Europe (Beerse, Belgium; High Wycombe, United Kingdom; Leiden, Netherlands; 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 Expert RA Professional Submissions, Submissions Management collaborates with colleagues to ensure compliance with regulatory agency regulations and interpretation. This position coordinates and compiles dossier plans/submission packages and may publish/dispatch. The Expert RA Professional Submissions may be responsible for the management and delivery of HA submissions. Special projects may be assigned and reviewed periodically.

In this role, you will:

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• Creates and manages the Dossier Plan(s)/Submission Packages for HA Submissions in line with clinical trials regulatory strategy. Seeks inputs from regulatory therapeutic areas, functional area representatives, and key stakeholders. Ensures that all required documents are included in the Dossier/Submission Package.
  
• Performs a dossier review of the published output.
  
• Tracks document status inside Dossier Plans with functional area owner.
  
• May lead submission team meetings. Works with partners to resolve issues (e.g., with time lines, document e-sub readiness, etc.).
  
• Monitors the effectiveness of the dossier process.
  
• Participates in special projects and process improvement initiatives, as needed. Supports development of departmental work practices, process enhancements / improvements, and associated training materials.
  
• May create and/or sign specific submission documents.
  
• Where appropriate, provides component-level publishing support for regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.).
  
• Utilizes regulatory information management systems and tools go across to compile and/or publish dossiers according to regulatory requirements for paper and electronic submissions.