Submissions & Regulatory Intelligence Manager

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 Med Tech, 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.

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Data Analytics & Computational Sciences

Clinical Data Management

Professional

High Wycombe, Buckinghamshire, United Kingdom

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.

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We are searching for the best talent for a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR), to contributes to the Clinical Data Standards team as an individual contributor and a developing subject matter expert, to take a leadership role in the collaboration with various internal and external partners. The Submissions & Regulatory Intelligence Manager provides expert guidance and implements tailored solutions on projects, programs, and processes that span multiple related areas in support of the organization's overall Clinical Data Standards strategy.

Foremost is ensuring consistency of clinical data standards across clinical trials and in compliance with regulatory requirements.

This role may be located in High Wycombe/Maidenhead, United Kingdom;
Beerse, Belgium;
Allschwil, Switzerland;
Leiden, Netherlands; or Spring House/Raritan/Titusville, United States (Hybrid / 3 days onsite per week preferred).

Please note that this role is also 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-103242
• United Kingdom
  - Requisition Number: R-101253
• Switzerland
  - Requisition Number: R-103247
• United States
  - Requisition Number: R-103251

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

• Acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization
• Manages standards, projects, programs, or processes for Clinical Data Standards in line with agreed internal strategy and regulatory requirements.
• Participates in the development of solutions to provide accurate, timely, and consistent clinical data standards to study teams
• Communicates ideas for process improvement, while supporting the design and integration of new technologies to enhance clinical data standards.
• Coaches and trains junior colleagues in clinical data standards application and responsibilities.
• Integrates Johnson & Johnson's Credo and Leadership Imperatives into team goals and decision making.

The Submissions & Regulatory Intelligence Manager is responsible for providing significant expertise to the IDAR department (and GD if applicable) in clinical study data regulatory submission requirements and strategies. Examples of this content are:

• Newly released or updated Regulatory Health Authority (RHA) and industry guidance documentation
• Identification of clinical study data submission information critical to IDAR submission processes and procedures, including providing an interpretation of such information if needed
• IDAR submission requirements and rules

The position serves as the single Point of Contact for any stakeholder on data management, clinical and statistical programming, and global…