Submissions & Reg. Intelligence Mgr

Johnson Johnson; Spring House (PA); Hybrid; USD 130,000 - 160,000; Full time

Job summary

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead regulatory submission strategies for clinical study data. The role collaborates with data management, statistics, and regulatory affairs to ensure compliant, timely submissions across multiple programs.

The successful candidate develops innovative solutions aligning with internal strategy and regulatory requirements, coaching junior staff and driving

Qualifications

• Expertise in clinical data standards and regulatory submission requirements.
• Experience guiding data management and statistical programming for submissions.
• Strong collaboration across stakeholders in regulatory affairs and IDAR.

Responsibilities

• Provide expert guidance on regulatory submission requirements and strategies for clinical study data.
• Identify critical submission information and interpret it for IDAR processes.
• Define IDAR submission requirements and rules.
• Serve as the single point of contact for data management, clinical/programming, and global regulatory affairs on deliverables.
• Coach/junior colleagues and align goals with Credo and leadership imperatives.

Skills

Regulatory submissions

Clinical data standards

Cross-functional leadership

Data management

Regulatory intelligence

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:

• 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 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 Submissions & Regulatory Intelligence Manager is responsib