Submissions & Regulatory Intelligence Manager

Johnson Johnson; High Wycombe; Hybrid; GBP 90,000 - 140,000; Full time

Job summary

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead clinical data standards initiatives. You will provide expert guidance on regulatory submission requirements, collaborate with partners, and drive standardization across trials while ensuring compliance.

The role may be based in multiple UK/EU locations with hybrid work and frequent cross-functional interaction to advance regulatory strategies and data quality.

Responsibilities

• Acts as top-level specialist to establish programs and innovative strategies for Clinical Data Standards
• Manages standards, projects, programs, or processes for Clinical Data Standards in line with internal strategy and regulatory requirements
• Participates in development of solutions to provide accurate, timely, and consistent clinical data standards
• Communicates ideas for process improvement and supports integration of new technologies
• Coaches and trains junior colleagues in clinical data standards application
• Integrates Credo and Leadership Imperatives into team goals and decisions

Job description

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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

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 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.

Purpose:

• 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.

You will be responsible for:

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 regulatory affairs, for data submission deliverable requirements and makes sure these teams have a very clear understanding of these deliverables, the need for compliance, the difference between RHA requirements and the general submission processes.

The Submissons & Regulatory Intelligence Manager is responsible for acquiring and maintaining deep expertise in current RHA and industry guidance and RHA validation