Submissions & Regulatory Intelligence Manager

Johnson And Johnson; High Wycombe; Hybride; GBP 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Flexible working environment

Career development opportunities

Competitive salary and benefits

Résumé du poste

Johnson & Johnson in the United Kingdom seeks a Submissions & Regulatory Intelligence Manager to lead clinical data submission strategies within IDAR. You will collaborate across data management, statistics, and regulatory affairs to ensure SDTM/ADaM readiness and regulatory compliance for NDA/BLA programs.

Candidates bring 6+ years in pharma data roles, strong GCP/ICH knowledge, and proven leadership. This hybrid role offers a structured path for professional growth and global collaboration.

Qualifications

• Bachelor’s degree in scientific, technology or healthcare discipline; advanced degrees preferred.
• 6+ years in pharmaceutical/scientific roles such as data management or biostatistics.
• Expert knowledge of regulatory requirements (GCP, ICH) and industry standards (SDTM, ADaM).
• Experience with regulatory submissions (NDA, BLA) is an asset.
• Demonstrated written and verbal communications skills.
• Demonstrated customer focus and solution‑oriented experience.
• Demonstrated interpersonal skills to build relationships with internal and external business partners.
• Demonstrated leadership on cross‑functional projects.
• Demonstrated leadership in decision making and problem solving.
• Excellent spoken and written English

Responsabilités

• Provide expert guidance on data submission requirements and strategies.
• Coordinate with data management, statistics, regulatory affairs for IDAR submissions.
• Lead on data standards programs and tool development.
• Coach junior staff and ensure regulatory compliance.

Connaissances

Advanced Analytics

Clinical Data Management

Clinical Trials Operations

Data Privacy Standards

Data Savvy

GCP

Regulatory Affairs Management

Research Ethics

Innovation

Technical Credibility

Formation

Bachelor’s degree in scientific, technology or healthcare discipline

Advanced degrees preferred (Master/PhD)

Description du poste

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/compliance rules in relation to data submission packages (e.g., SDTM/ADaM submission packages).

The position supports the ownership by SRI of any tools, system, checklists templates, etc., that facilitate data package compliance checking for IDAR. The position may serve as the lead of the Submission Center of Excellence, serving as POC for study teams requesting SubCOE support, responsible for workload distribution amongst the team, working at the trial level post‑DBL to ensure SDTM, ADaM, and documentation submission‑readiness.

Qualifications / Requirements:

• A Bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience.
• Advanced degrees preferred (e.g., Master, PhD)
• At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming!
• Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM)
• Experience with regulatory submissions (NDA, BLA) is an asset
• Demonstrated written and verbal communications skills
• Demonstrated customer focus and solution‑oriented experience
• Demonstrated interpersonal skills to build relationships with internal and external business partners
• Demonstrated leadership on cross‑functional projects
• Demonstrated leadership in decision making and problem solving
• Excellent spoken and written English

Benefits:

• We offer a competitive salary and extensive benefits package.
• The health and well‑being of our employees is a priority, we have a flexible working environment as we value work‑life balance.
• We offer career development opportunities for those who want to grow and be part of our organisation.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.

Required Skills:

#LI-Hybrid Required Skills: Preferred Skills: Advanced Analytics, Clinical Data Management, Clinical Trials Operations, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Innovation, Leverages Information, Process Improvements, Regulatory Affairs Management, Research Ethics, Technical Credibility